Trial Outcomes & Findings for Trial to Evaluate the Safety and Pharmacokinetics of HMPL-689 in Patients With Lymphomas (NCT NCT03786926)
NCT ID: NCT03786926
Last Updated: 2025-06-26
Results Overview
A DLT was defined as the occurrence of any of the following treatment-emergent adverse events (TEAEs) during the DLT assessment window, unless equivocally due to underlying malignancy or an extraneous cause. AEs were graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0: non-hematologic toxicity: all non-hematologic TEAEs of grade 3 or greater with the exception of grade 3 nausea or vomiting that could be controlled by supportive therapy; hematologic toxicity: grade 4 neutropenia \>5 days, grade 4 thrombocytopenia or grade 3 thrombocytopenia with bleeding event or requiring platelet transfusion, grade \>=3 febrile neutropenia (defined as absolute neutrophil count \[ANC\] \<1000/cubic millimeter {mm\^3} with a single temperature \>38.3 degree Celsius \[°C\] or a sustained temperature of \>=38°C for more than 1 hour), grade 4 anemia not explained by underlying disease; any TEAE that required a dose delay of \>=15 days; any case of Hy's Law.
TERMINATED
PHASE1
53 participants
From the first dose of study drug (Day 1) up to Day 28 of Cycle 1 (each cycle is 28 days)
2025-06-26
Participant Flow
This Phase 1, 2-part, open-label study was conducted in patients with relapsed, refractory, or resistant lymphoma.
The study consisted of a dose escalation stage (stage 1) and a dose expansion stage (stage 2). A total of 23 patients in dose escalation stage and 30 patients in dose expansion stage were enrolled in this study. The study was terminated based on strategic evaluation of the clinical development of HMPL-689 in the United States, Europe, and Australia with no safety concerns.
Participant milestones
| Measure |
Dose Escalation Stage: HMPL-689 5 mg QD
Patients received HMPL-689 5 milligram (mg) once daily (QD) orally for continuous 28-day treatment cycles until disease progression (PD), death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 10 mg QD
Patients received HMPL-689 10 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 15 mg QD
Patients received HMPL-689 15 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 20 mg QD
Patients received HMPL-689 20 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 25 mg QD
Patients received HMPL-689 25 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 30 mg QD
Patients received HMPL-689 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: CLL/SLL
Patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) received HMPL-689 at recommended phase 2 dose (RP2D), that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: FL
Patients with follicular lymphoma (FL) received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: MZL
Patient with marginal zone lymphoma (MZL) received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: LPL/WM
Patients with lymphoplasmacytic lymphoma/Waldenström's macroglobulinemia (LPL/WM) received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: MCL
Patients with mantle cell lymphoma (MCL) received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
5
|
3
|
6
|
3
|
3
|
13
|
6
|
3
|
5
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
5
|
3
|
6
|
3
|
3
|
13
|
6
|
3
|
5
|
Reasons for withdrawal
| Measure |
Dose Escalation Stage: HMPL-689 5 mg QD
Patients received HMPL-689 5 milligram (mg) once daily (QD) orally for continuous 28-day treatment cycles until disease progression (PD), death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 10 mg QD
Patients received HMPL-689 10 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 15 mg QD
Patients received HMPL-689 15 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 20 mg QD
Patients received HMPL-689 20 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 25 mg QD
Patients received HMPL-689 25 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 30 mg QD
Patients received HMPL-689 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: CLL/SLL
Patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) received HMPL-689 at recommended phase 2 dose (RP2D), that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: FL
Patients with follicular lymphoma (FL) received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: MZL
Patient with marginal zone lymphoma (MZL) received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: LPL/WM
Patients with lymphoplasmacytic lymphoma/Waldenström's macroglobulinemia (LPL/WM) received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: MCL
Patients with mantle cell lymphoma (MCL) received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
1
|
|
Overall Study
Progressive disease
|
3
|
0
|
3
|
1
|
2
|
2
|
1
|
6
|
1
|
1
|
1
|
|
Overall Study
Death
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
1
|
2
|
0
|
0
|
2
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
1
|
|
Overall Study
Study terminated by Sponsor
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
4
|
0
|
0
|
0
|
|
Overall Study
Anti-neoplasm treatment
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Other
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
2
|
0
|
0
|
Baseline Characteristics
Trial to Evaluate the Safety and Pharmacokinetics of HMPL-689 in Patients With Lymphomas
Baseline characteristics by cohort
| Measure |
Dose Escalation Stage: HMPL-689 5 mg QD
n=3 Participants
Patients received HMPL-689 5 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 10 mg QD
n=3 Participants
Patients received HMPL-689 10 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 15 mg QD
n=5 Participants
Patients received HMPL-689 15 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 20 mg QD
n=3 Participants
Patients received HMPL-689 20 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 25 mg QD
n=6 Participants
Patients received HMPL-689 25 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 30 mg QD
n=3 Participants
Patients received HMPL-689 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: CLL/SLL
n=3 Participants
Patients with CLL/SLL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: FL
n=13 Participants
Patients with FL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: MZL
n=6 Participants
Patient with MZL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: LPL/WM
n=3 Participants
Patients with LPL/WM received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: MCL
n=5 Participants
Patients with MCL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
69.7 years
STANDARD_DEVIATION 6.51 • n=5 Participants
|
70.7 years
STANDARD_DEVIATION 13.05 • n=7 Participants
|
64.8 years
STANDARD_DEVIATION 17.18 • n=5 Participants
|
67.7 years
STANDARD_DEVIATION 3.51 • n=4 Participants
|
63.8 years
STANDARD_DEVIATION 7.68 • n=21 Participants
|
59.0 years
STANDARD_DEVIATION 17.69 • n=8 Participants
|
65.7 years
STANDARD_DEVIATION 5.03 • n=8 Participants
|
61.7 years
STANDARD_DEVIATION 10.16 • n=24 Participants
|
72.3 years
STANDARD_DEVIATION 9.56 • n=42 Participants
|
63.7 years
STANDARD_DEVIATION 4.16 • n=42 Participants
|
75.8 years
STANDARD_DEVIATION 8.23 • n=42 Participants
|
66.2 years
STANDARD_DEVIATION 10.63 • n=42 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
9 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
21 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
32 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
13 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
52 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
10 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
43 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: From the first dose of study drug (Day 1) up to Day 28 of Cycle 1 (each cycle is 28 days)Population: The DLT evaluable analysis set (DEAS) was defined as all patients enrolled in the dose escalation stage of the study who were evaluable for DLT assessment. A patient was DLT evaluable if: had received at least 75% of the assigned dose of study drug during the DLT assessment window or had not completed the DLT assessment period due to a DLT.
A DLT was defined as the occurrence of any of the following treatment-emergent adverse events (TEAEs) during the DLT assessment window, unless equivocally due to underlying malignancy or an extraneous cause. AEs were graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0: non-hematologic toxicity: all non-hematologic TEAEs of grade 3 or greater with the exception of grade 3 nausea or vomiting that could be controlled by supportive therapy; hematologic toxicity: grade 4 neutropenia \>5 days, grade 4 thrombocytopenia or grade 3 thrombocytopenia with bleeding event or requiring platelet transfusion, grade \>=3 febrile neutropenia (defined as absolute neutrophil count \[ANC\] \<1000/cubic millimeter {mm\^3} with a single temperature \>38.3 degree Celsius \[°C\] or a sustained temperature of \>=38°C for more than 1 hour), grade 4 anemia not explained by underlying disease; any TEAE that required a dose delay of \>=15 days; any case of Hy's Law.
Outcome measures
| Measure |
Dose Escalation Stage: HMPL-689 5 mg QD
n=3 Participants
Patients received HMPL-689 5 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 10 mg QD
n=3 Participants
Patients received HMPL-689 10 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 15 mg QD
n=5 Participants
Patients received HMPL-689 15 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 20 mg QD
n=3 Participants
Patients received HMPL-689 20 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 25 mg QD
n=6 Participants
Patients received HMPL-689 25 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 30 mg QD
n=3 Participants
Patients received HMPL-689 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: CLL/SLL
Patients with CLL/SLL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: FL
Patients with FL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: MZL
Patient with MZL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: LPL/WM
Patients with LPL/WM received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: MCL
Patients with MCL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Stage: Number of Patients With Dose-Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 monthsPopulation: The FAS included all patients who received at least 1 dose of HMPL-689.
An AE was any untoward medical occurrence in a clinical investigation patient administered a study drug, regardless of causal attribution. An SAE was an AE that resulted in any of the following: was fatal, was life threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect in a neonate/infant born to a female patient or female partner of a male patient exposed to the study drug, or was considered a significant medical event by the investigator. TEAEs were defined as AEs with onset date on or after the first dose of study drug and no later than 30 days after the date of last study drug administration or start of a new study drug of anti-neoplasm therapy, whichever was earlier. Treatment related AEs and SAEs were defined as AEs and SAEs collected later than 30 days after the last study drug date or start of a new study drug of anti-neoplasm therapy.
Outcome measures
| Measure |
Dose Escalation Stage: HMPL-689 5 mg QD
n=3 Participants
Patients received HMPL-689 5 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 10 mg QD
n=3 Participants
Patients received HMPL-689 10 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 15 mg QD
n=5 Participants
Patients received HMPL-689 15 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 20 mg QD
n=3 Participants
Patients received HMPL-689 20 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 25 mg QD
n=6 Participants
Patients received HMPL-689 25 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 30 mg QD
n=3 Participants
Patients received HMPL-689 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: CLL/SLL
Patients with CLL/SLL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: FL
Patients with FL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: MZL
Patient with MZL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: LPL/WM
Patients with LPL/WM received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: MCL
Patients with MCL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Stage: Number of Patients With Treatment-Emergent Adverse Events (TEAEs), Treatment Related Treatment-Emergent Adverse Events (TRAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment Related Serious Adverse Events (TRSAEs)
Any TEAE
|
3 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Stage: Number of Patients With Treatment-Emergent Adverse Events (TEAEs), Treatment Related Treatment-Emergent Adverse Events (TRAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment Related Serious Adverse Events (TRSAEs)
Any TRAE
|
1 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Stage: Number of Patients With Treatment-Emergent Adverse Events (TEAEs), Treatment Related Treatment-Emergent Adverse Events (TRAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment Related Serious Adverse Events (TRSAEs)
Any TESAE
|
0 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Stage: Number of Patients With Treatment-Emergent Adverse Events (TEAEs), Treatment Related Treatment-Emergent Adverse Events (TRAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment Related Serious Adverse Events (TRSAEs)
Any TRSAE
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 27 monthsPopulation: The FAS included all patients who received at least 1 dose of HMPL-689.
An AE was any untoward medical occurrence in a clinical investigation patient administered a study drug, regardless of causal attribution. TEAEs were defined as AEs with onset date on or after the first dose of study drug and no later than 30 days after the date of last study drug administration or start of a new study drug of anti-neoplasm therapy, whichever was earlier. Treatment related AEs were defined as AEs collected later than 30 days after the last study drug date or start of a new study drug of anti-neoplasm therapy.
Outcome measures
| Measure |
Dose Escalation Stage: HMPL-689 5 mg QD
n=3 Participants
Patients received HMPL-689 5 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 10 mg QD
n=13 Participants
Patients received HMPL-689 10 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 15 mg QD
n=6 Participants
Patients received HMPL-689 15 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 20 mg QD
n=3 Participants
Patients received HMPL-689 20 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 25 mg QD
n=5 Participants
Patients received HMPL-689 25 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 30 mg QD
Patients received HMPL-689 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: CLL/SLL
Patients with CLL/SLL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: FL
Patients with FL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: MZL
Patient with MZL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: LPL/WM
Patients with LPL/WM received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: MCL
Patients with MCL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Expansion Stage: Number of Patients With Treatment-Emergent Adverse Events and Treatment Related Treatment-Emergent Adverse Events
Any TRAE
|
3 Participants
|
12 Participants
|
5 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Stage: Number of Patients With Treatment-Emergent Adverse Events and Treatment Related Treatment-Emergent Adverse Events
Any TEAE
|
3 Participants
|
13 Participants
|
5 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-7days) thereafter, up to a maximum of 58 monthsPopulation: The efficacy analysis set (EAS) included all patients who received at least 1 dose of HMPL-689 and had a baseline tumor assessment and at least 1 evaluable post-baseline assessment unless death occurred before the first post-baseline assessment.
ORR: percentage of patients with complete response (CR),CR with incomplete marrow recovery (CRi),nodular partial response (nPR),PR with lymphocytosis (PR-L) or PR for CLL patients; CR, very good PR (VGPR),PR or minor response (MR) for WM patients;CR or PR for patients with disease other than CLL and WM.CR: absence of serum (S) monoclonal immunoglobulin (Ig)M, normal S IgM, complete resolution of extramedullary disease,morphologically normal bone marrow aspirate and trephine biopsy. CRi:criteria fulfilled for CR but persistent cytopenia,anemia,thrombocytopenia or neutropenia. nPR:patients with residual CLL cells.PR-L:patients achieved PR with CLL-related signs/symptoms other than lymphocytosis and continued on therapy.PR, VGPR, MR: detectable monoclonal IgM,no new signs/symptoms of active disease and PR: ≥50% but \<90% reduction in S IgM,reduction in extramedullary disease,VGPR: \>=90% reduction in S IgM,complete resolution of extramedullary disease,MR: \>=25% but \<50% reduction in S IgM.
Outcome measures
| Measure |
Dose Escalation Stage: HMPL-689 5 mg QD
n=3 Participants
Patients received HMPL-689 5 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 10 mg QD
n=3 Participants
Patients received HMPL-689 10 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 15 mg QD
n=5 Participants
Patients received HMPL-689 15 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 20 mg QD
n=2 Participants
Patients received HMPL-689 20 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 25 mg QD
n=5 Participants
Patients received HMPL-689 25 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 30 mg QD
n=3 Participants
Patients received HMPL-689 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: CLL/SLL
n=3 Participants
Patients with CLL/SLL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: FL
n=13 Participants
Patients with FL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: MZL
n=6 Participants
Patient with MZL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: LPL/WM
n=2 Participants
Patients with LPL/WM received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: MCL
n=4 Participants
Patients with MCL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation and Dose Expansion Stages: Objective Response Rate (ORR)
|
33.3 percentage of patients
Interval 0.8 to 90.6
|
66.7 percentage of patients
Interval 9.4 to 99.2
|
80.0 percentage of patients
Interval 28.4 to 99.5
|
100.0 percentage of patients
Interval 15.8 to 100.0
|
60.0 percentage of patients
Interval 14.7 to 94.7
|
66.7 percentage of patients
Interval 9.4 to 99.2
|
66.7 percentage of patients
Interval 9.4 to 99.2
|
84.6 percentage of patients
Interval 54.6 to 98.1
|
50.0 percentage of patients
Interval 11.8 to 88.2
|
100.0 percentage of patients
Interval 15.8 to 100.0
|
100.0 percentage of patients
Interval 39.8 to 100.0
|
SECONDARY outcome
Timeframe: Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-7days) thereafter, up to a maximum of 58 monthsPopulation: The EAS included all patients who received at least 1 dose of HMPL-689 and had a baseline tumor assessment and at least 1 evaluable post-baseline assessment unless death occurred before the first post-baseline assessment. Only patients with CR, CRi, PR, nPR, VGPR, PR-L, or MR were included in the analysis.
TTR was defined as the time from the first dose of study drug to the first occurrence of CR, CRi, PR, nPR, VGPR, PR-L, or MR. CR: absence of serum monoclonal IgM, normal serum IgM, complete resolution of extramedullary disease, morphologically normal bone marrow aspirate and trephine biopsy. CRi: criteria fulfilled for CR but persistent cytopenia, anemia, thrombocytopenia or neutropenia. PR: detectable monoclonal IgM, no new signs/symptoms of active disease, 50% but \<90% reduction in serum IgM, reduction in extramedullary disease. nPR: patients with residual CLL cells. VGPR: detectable monoclonal IgM, no new signs/symptoms of active disease,\>=90% reduction in serum IgM, complete resolution of extramedullary disease. PR-L: patients achieved PR with CLL-related signs/symptoms other than lymphocytosis and continued on therapy. MR: detectable monoclonal IgM, no new signs/symptoms of active disease, \>=25% but \<50% reduction in serum IgM.
Outcome measures
| Measure |
Dose Escalation Stage: HMPL-689 5 mg QD
n=1 Participants
Patients received HMPL-689 5 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 10 mg QD
n=2 Participants
Patients received HMPL-689 10 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 15 mg QD
n=4 Participants
Patients received HMPL-689 15 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 20 mg QD
n=2 Participants
Patients received HMPL-689 20 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 25 mg QD
n=3 Participants
Patients received HMPL-689 25 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 30 mg QD
n=2 Participants
Patients received HMPL-689 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: CLL/SLL
n=2 Participants
Patients with CLL/SLL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: FL
n=11 Participants
Patients with FL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: MZL
n=3 Participants
Patient with MZL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: LPL/WM
n=2 Participants
Patients with LPL/WM received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: MCL
n=4 Participants
Patients with MCL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation and Dose Expansion Stages: Time to Response (TTR)
|
1.87 months
Interval 1.87 to 1.87
|
1.72 months
Interval 1.68 to 1.77
|
8.80 months
Interval 1.91 to 19.55
|
1.77 months
Interval 1.68 to 1.87
|
2.27 months
Interval 1.87 to 11.14
|
1.84 months
Interval 1.84 to 1.84
|
2.81 months
Interval 1.87 to 3.75
|
1.74 months
Interval 1.64 to 2.07
|
2.53 months
Interval 1.91 to 2.79
|
3.73 months
Interval 1.84 to 5.62
|
1.76 months
Interval 1.71 to 1.84
|
SECONDARY outcome
Timeframe: Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-7days) thereafter, up to a maximum of 58 monthsPopulation: The EAS included all patients who received at least 1 dose of HMPL-689 and had a baseline tumor assessment and at least 1 evaluable post-baseline assessment unless death occurred before the first post-baseline assessment. Only patients with CR, CRi, PR, nPR, VGPR, PR-L, or MR were included in the analysis.
DOR: time from when first response (CR, CRi, PR, nPR, VGPR, PR-L and MR) was achieved until earlier of first documentation of definitive PD or death from any cause, whichever was earlier. CR: absence of S monoclonal IgM, normal S IgM, complete resolution of extramedullary disease, morphologically normal bone marrow aspirate and trephine biopsy. CRi: criteria fulfilled for CR but persistent cytopenia, anemia, thrombocytopenia or neutropenia. nPR: patients with residual CLL cells. PR-L: patients achieved PR with CLL-related signs/symptoms other than lymphocytosis and continued on therapy. PR, VGPR, MR: detectable monoclonal IgM, no new signs/symptoms of active disease and PR: ≥50% but \<90% reduction in S IgM, reduction in extramedullary disease, VGPR: \>=90% reduction in S IgM, complete resolution of extramedullary disease, MR: \>=25% but \<50% reduction in S IgM. PD: \>=25% increase in S IgM level from lowest nadir and/or progression in clinical features attributable to the disease.
Outcome measures
| Measure |
Dose Escalation Stage: HMPL-689 5 mg QD
n=1 Participants
Patients received HMPL-689 5 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 10 mg QD
n=2 Participants
Patients received HMPL-689 10 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 15 mg QD
n=4 Participants
Patients received HMPL-689 15 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 20 mg QD
n=2 Participants
Patients received HMPL-689 20 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 25 mg QD
n=3 Participants
Patients received HMPL-689 25 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 30 mg QD
n=2 Participants
Patients received HMPL-689 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: CLL/SLL
n=2 Participants
Patients with CLL/SLL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: FL
n=11 Participants
Patients with FL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: MZL
n=3 Participants
Patient with MZL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: LPL/WM
n=2 Participants
Patients with LPL/WM received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: MCL
n=4 Participants
Patients with MCL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation and Dose Expansion Stages: Duration of Response (DOR)
|
1.9 months
NA indicates that upper and lower limits of confidence interval (CI) were not estimable due to insufficient number of patients with events at study closure.
|
31.9 months
NA indicates that upper and lower limits of CI were not estimable due to insufficient number of patients with events at study closure.
|
13.7 months
Interval 12.6 to
NA indicates that upper limit of CI was not estimable due to insufficient number of patients with events at study closure.
|
NA months
Interval 9.3 to
NA indicates that median and upper limit of CI were not estimable due to insufficient number of patients with events at study closure.
|
NA months
NA indicates that median, upper and lower limits of CI were not estimable due to insufficient number of patients with events at study closure.
|
NA months
Interval 1.9 to
NA indicates that median and upper limit of CI were not estimable due to insufficient number of patients with events at study closure.
|
NA months
Interval 4.6 to
NA indicates that median and upper limit of CI were not estimable due to insufficient number of patients with events at study closure.
|
NA months
Interval 1.9 to
NA indicates that median and upper limit of CI were not estimable due to insufficient number of patients with events at study closure.
|
NA months
NA indicates that median, upper and lower limits of CI were not estimable due to insufficient number of patients with events at study closure.
|
NA months
Interval 4.9 to
NA indicates that median and upper limit of CI were not estimable due to insufficient number of patients with events at study closure.
|
9.1 months
Interval 3.7 to
NA indicates that upper limit of CI was not estimable due to insufficient number of patients with events at study closure.
|
SECONDARY outcome
Timeframe: Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-7 days) thereafter, up to a maximum of 58 monthsPopulation: The EAS included all patients who received at least 1 dose of HMPL-689 and had a baseline tumor assessment and at least 1 evaluable post-baseline assessment unless death occurred before the first post-baseline assessment.
CBR was defined as percentage of patients who had best overall response (BOR) with stable disease (SD) or better. BOR was defined as the best response recorded from the start of treatment until PD or new anti-cancer therapy, whichever came earlier. PD: \>=25% increase in serum IgM level from lowest nadir and/or progression in clinical features attributable to the disease. SD: detectable monoclonal IgM, \<25% reduction and \<25% increase in serum IgM level, no progression in extramedullary disease, no new signs/symptoms of active disease.
Outcome measures
| Measure |
Dose Escalation Stage: HMPL-689 5 mg QD
n=3 Participants
Patients received HMPL-689 5 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 10 mg QD
n=3 Participants
Patients received HMPL-689 10 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 15 mg QD
n=5 Participants
Patients received HMPL-689 15 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 20 mg QD
n=2 Participants
Patients received HMPL-689 20 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 25 mg QD
n=5 Participants
Patients received HMPL-689 25 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 30 mg QD
n=3 Participants
Patients received HMPL-689 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: CLL/SLL
n=3 Participants
Patients with CLL/SLL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: FL
n=13 Participants
Patients with FL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: MZL
n=6 Participants
Patient with MZL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: LPL/WM
n=2 Participants
Patients with LPL/WM received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: MCL
n=4 Participants
Patients with MCL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation and Dose Expansion Stages: Clinical Benefit Rate (CBR)
|
100.0 percentage of patients
Interval 29.2 to 100.0
|
100.0 percentage of patients
Interval 29.2 to 100.0
|
80.0 percentage of patients
Interval 28.4 to 99.5
|
100.0 percentage of patients
Interval 15.8 to 100.0
|
80.0 percentage of patients
Interval 28.4 to 99.5
|
66.7 percentage of patients
Interval 9.4 to 99.2
|
100.0 percentage of patients
Interval 29.2 to 100.0
|
84.6 percentage of patients
Interval 54.6 to 98.1
|
83.3 percentage of patients
Interval 35.9 to 99.6
|
100.0 percentage of patients
Interval 15.8 to 100.0
|
100.0 percentage of patients
Interval 39.8 to 100.0
|
SECONDARY outcome
Timeframe: Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-7 days) thereafter, up to a maximum of 58 monthsPopulation: The FAS included all patients who received at least 1 dose of HMPL-689.
PFS was defined as the time from the date of first study drug to the earliest date of PD or death of any cause, whichever occurred first. PD was defined as \>=25% increase in serum IgM level from lowest nadir and/or progression in clinical features attributable to the disease.
Outcome measures
| Measure |
Dose Escalation Stage: HMPL-689 5 mg QD
n=3 Participants
Patients received HMPL-689 5 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 10 mg QD
n=3 Participants
Patients received HMPL-689 10 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 15 mg QD
n=5 Participants
Patients received HMPL-689 15 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 20 mg QD
n=3 Participants
Patients received HMPL-689 20 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 25 mg QD
n=6 Participants
Patients received HMPL-689 25 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 30 mg QD
n=3 Participants
Patients received HMPL-689 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: CLL/SLL
n=3 Participants
Patients with CLL/SLL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: FL
n=13 Participants
Patients with FL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: MZL
n=6 Participants
Patient with MZL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: LPL/WM
n=3 Participants
Patients with LPL/WM received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: MCL
n=5 Participants
Patients with MCL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation and Dose Expansion Stages: Progression-Free Survival (PFS)
|
5.3 months
Interval 3.8 to
NA indicates that upper limit of CI was not estimable due to insufficient number of patients with events at study closure.
|
33.6 months
NA indicates that upper and lower limits of CI were not estimable due to insufficient number of patients with events at study closure.
|
16.6 months
Interval 1.9 to
NA indicates that upper limit of CI was not estimable due to insufficient number of patients with events at study closure.
|
NA months
Interval 11.0 to
NA indicates that median and upper limit of CI were not estimable due to insufficient number of patients with events at study closure.
|
13.6 months
Interval 1.8 to
NA indicates that upper limit of CI was not estimable due to insufficient number of patients with events at study closure.
|
3.7 months
Interval 1.7 to
NA indicates that upper limit of CI was not estimable due to insufficient number of patients with events at study closure.
|
NA months
Interval 8.3 to
NA indicates that median and upper limit of CI were not estimable due to insufficient number of patients with events at study closure.
|
11.9 months
Interval 1.8 to
NA indicates that upper limit of CI was not estimable due to insufficient number of patients with events at study closure.
|
5.6 months
Interval 2.1 to
NA indicates that upper limit of CI was not estimable due to insufficient number of patients with events at study closure.
|
NA months
Interval 10.4 to
NA indicates that median and upper limit of CI were not estimable due to insufficient number of patients with events at study closure.
|
10.8 months
Interval 5.5 to
NA indicates that upper limit of CI was not estimable due to insufficient number of patients with events at study closure.
|
SECONDARY outcome
Timeframe: Pre-dose on Days 1, 2, 15, 16, 28 of Cycle 1 and on Day 1 of Cycle 2; 0.5, 1, 2, 4 and 8 hours post-dose on Days 1, 15 and 28 of Cycle 1 (each cycle is 28 days)Population: The pharmacokinetic analysis set (PKAS) included all patients who received at least 1 dose of HMPL-689 and had at least 1 PK sample obtained and analyzed. Only patients with data collected at specified timepoints are reported.
Blood samples were collected to determine plasma concentration of HMPL-689. The pharmacokinetic (PK) parameters were determined by non-compartmental analysis.
Outcome measures
| Measure |
Dose Escalation Stage: HMPL-689 5 mg QD
n=3 Participants
Patients received HMPL-689 5 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 10 mg QD
n=3 Participants
Patients received HMPL-689 10 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 15 mg QD
n=5 Participants
Patients received HMPL-689 15 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 20 mg QD
n=3 Participants
Patients received HMPL-689 20 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 25 mg QD
n=6 Participants
Patients received HMPL-689 25 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 30 mg QD
n=3 Participants
Patients received HMPL-689 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: CLL/SLL
Patients with CLL/SLL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: FL
Patients with FL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: MZL
Patient with MZL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: LPL/WM
Patients with LPL/WM received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: MCL
Patients with MCL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Stage: Plasma Concentration of HMPL-689
Pre-dose: Day 1 Cycle 1
|
0.000 nanograms per milliliter (ng/mL)
Standard Deviation 0.000
|
0.000 nanograms per milliliter (ng/mL)
Standard Deviation 0.000
|
0.000 nanograms per milliliter (ng/mL)
Standard Deviation 0.000
|
0.000 nanograms per milliliter (ng/mL)
Standard Deviation 0.000
|
0.000 nanograms per milliliter (ng/mL)
Standard Deviation 0.000
|
0.000 nanograms per milliliter (ng/mL)
Standard Deviation 0.000
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Stage: Plasma Concentration of HMPL-689
0.5 hour post-dose: Day 1 Cycle 1
|
1.153 nanograms per milliliter (ng/mL)
Standard Deviation 1.220
|
65.133 nanograms per milliliter (ng/mL)
Standard Deviation 72.976
|
19.322 nanograms per milliliter (ng/mL)
Standard Deviation 18.574
|
87.733 nanograms per milliliter (ng/mL)
Standard Deviation 68.441
|
47.424 nanograms per milliliter (ng/mL)
Standard Deviation 78.327
|
36.907 nanograms per milliliter (ng/mL)
Standard Deviation 32.999
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Stage: Plasma Concentration of HMPL-689
1 hour post-dose: Day 1 Cycle 1
|
14.457 nanograms per milliliter (ng/mL)
Standard Deviation 14.965
|
71.346 nanograms per milliliter (ng/mL)
Standard Deviation 63.493
|
66.740 nanograms per milliliter (ng/mL)
Standard Deviation 41.460
|
125.100 nanograms per milliliter (ng/mL)
Standard Deviation 78.083
|
110.780 nanograms per milliliter (ng/mL)
Standard Deviation 70.347
|
184.000 nanograms per milliliter (ng/mL)
Standard Deviation 176.952
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Stage: Plasma Concentration of HMPL-689
2 hours post-dose: Day 1 Cycle 1
|
22.200 nanograms per milliliter (ng/mL)
Standard Deviation 4.629
|
50.887 nanograms per milliliter (ng/mL)
Standard Deviation 41.833
|
98.260 nanograms per milliliter (ng/mL)
Standard Deviation 16.955
|
108.067 nanograms per milliliter (ng/mL)
Standard Deviation 27.749
|
141.600 nanograms per milliliter (ng/mL)
Standard Deviation 82.032
|
167.033 nanograms per milliliter (ng/mL)
Standard Deviation 75.883
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Stage: Plasma Concentration of HMPL-689
4 hours post-dose: Day 1 Cycle 1
|
19.267 nanograms per milliliter (ng/mL)
Standard Deviation 4.186
|
44.467 nanograms per milliliter (ng/mL)
Standard Deviation 22.299
|
95.260 nanograms per milliliter (ng/mL)
Standard Deviation 33.323
|
67.367 nanograms per milliliter (ng/mL)
Standard Deviation 30.596
|
103.700 nanograms per milliliter (ng/mL)
Standard Deviation 33.787
|
111.533 nanograms per milliliter (ng/mL)
Standard Deviation 49.843
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Stage: Plasma Concentration of HMPL-689
8 hours post-dose: Day 1 Cycle 1
|
15.100 nanograms per milliliter (ng/mL)
Standard Deviation 4.190
|
35.867 nanograms per milliliter (ng/mL)
Standard Deviation 9.063
|
48.440 nanograms per milliliter (ng/mL)
Standard Deviation 18.373
|
36.700 nanograms per milliliter (ng/mL)
Standard Deviation 13.981
|
68.120 nanograms per milliliter (ng/mL)
Standard Deviation 27.164
|
72.600 nanograms per milliliter (ng/mL)
Standard Deviation 19.128
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Stage: Plasma Concentration of HMPL-689
Pre-dose: Day 2 Cycle 1
|
4.490 nanograms per milliliter (ng/mL)
Standard Deviation 1.360
|
11.527 nanograms per milliliter (ng/mL)
Standard Deviation 6.411
|
12.442 nanograms per milliliter (ng/mL)
Standard Deviation 5.112
|
8.887 nanograms per milliliter (ng/mL)
Standard Deviation 4.148
|
20.017 nanograms per milliliter (ng/mL)
Standard Deviation 8.614
|
13.433 nanograms per milliliter (ng/mL)
Standard Deviation 1.501
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Stage: Plasma Concentration of HMPL-689
Pre-dose: Day 15 Cycle 1
|
4.580 nanograms per milliliter (ng/mL)
Standard Deviation 0.521
|
35.613 nanograms per milliliter (ng/mL)
Standard Deviation 39.872
|
12.450 nanograms per milliliter (ng/mL)
Standard Deviation 9.931
|
11.100 nanograms per milliliter (ng/mL)
Standard Deviation 10.026
|
29.250 nanograms per milliliter (ng/mL)
Standard Deviation 14.562
|
22.900 nanograms per milliliter (ng/mL)
Standard Deviation 11.077
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Stage: Plasma Concentration of HMPL-689
0.5 hour post-dose: Day 15 Cycle 1
|
5.443 nanograms per milliliter (ng/mL)
Standard Deviation 2.145
|
118.433 nanograms per milliliter (ng/mL)
Standard Deviation 82.709
|
44.295 nanograms per milliliter (ng/mL)
Standard Deviation 40.717
|
59.667 nanograms per milliliter (ng/mL)
Standard Deviation 52.905
|
45.180 nanograms per milliliter (ng/mL)
Standard Deviation 29.456
|
21.733 nanograms per milliliter (ng/mL)
Standard Deviation 9.166
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Stage: Plasma Concentration of HMPL-689
1 hour post-dose: Day 15 Cycle 1
|
19.300 nanograms per milliliter (ng/mL)
Standard Deviation 26.414
|
115.400 nanograms per milliliter (ng/mL)
Standard Deviation 69.730
|
66.900 nanograms per milliliter (ng/mL)
Standard Deviation 50.101
|
100.667 nanograms per milliliter (ng/mL)
Standard Deviation 63.801
|
94.420 nanograms per milliliter (ng/mL)
Standard Deviation 72.734
|
116.667 nanograms per milliliter (ng/mL)
Standard Deviation 16.773
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Stage: Plasma Concentration of HMPL-689
2 hours post-dose: Day 15 Cycle 1
|
31.123 nanograms per milliliter (ng/mL)
Standard Deviation 24.388
|
79.867 nanograms per milliliter (ng/mL)
Standard Deviation 23.500
|
86.425 nanograms per milliliter (ng/mL)
Standard Deviation 42.718
|
102.900 nanograms per milliliter (ng/mL)
Standard Deviation 22.999
|
122.220 nanograms per milliliter (ng/mL)
Standard Deviation 86.832
|
187.333 nanograms per milliliter (ng/mL)
Standard Deviation 88.636
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Stage: Plasma Concentration of HMPL-689
4 hours post-dose: Day 15 Cycle 1
|
20.323 nanograms per milliliter (ng/mL)
Standard Deviation 11.020
|
56.200 nanograms per milliliter (ng/mL)
Standard Deviation 22.311
|
91.625 nanograms per milliliter (ng/mL)
Standard Deviation 31.814
|
97.667 nanograms per milliliter (ng/mL)
Standard Deviation 14.468
|
153.400 nanograms per milliliter (ng/mL)
Standard Deviation 30.345
|
158.833 nanograms per milliliter (ng/mL)
Standard Deviation 63.135
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Stage: Plasma Concentration of HMPL-689
8 hours post-dose: Day 15 Cycle 1
|
15.933 nanograms per milliliter (ng/mL)
Standard Deviation 2.307
|
37.533 nanograms per milliliter (ng/mL)
Standard Deviation 16.861
|
73.233 nanograms per milliliter (ng/mL)
Standard Deviation 14.758
|
58.450 nanograms per milliliter (ng/mL)
Standard Deviation 9.122
|
87.620 nanograms per milliliter (ng/mL)
Standard Deviation 26.685
|
77.367 nanograms per milliliter (ng/mL)
Standard Deviation 25.143
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Stage: Plasma Concentration of HMPL-689
Pre-dose: Day 16 Cycle 1
|
5.567 nanograms per milliliter (ng/mL)
Standard Deviation 0.958
|
61.367 nanograms per milliliter (ng/mL)
Standard Deviation 87.227
|
17.825 nanograms per milliliter (ng/mL)
Standard Deviation 4.234
|
15.100 nanograms per milliliter (ng/mL)
Standard Deviation 1.556
|
31.320 nanograms per milliliter (ng/mL)
Standard Deviation 13.989
|
20.267 nanograms per milliliter (ng/mL)
Standard Deviation 9.393
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Stage: Plasma Concentration of HMPL-689
Pre-dose: Day 28 Cycle 1
|
5.837 nanograms per milliliter (ng/mL)
Standard Deviation 1.257
|
10.885 nanograms per milliliter (ng/mL)
Standard Deviation 1.860
|
19.575 nanograms per milliliter (ng/mL)
Standard Deviation 9.215
|
25.133 nanograms per milliliter (ng/mL)
Standard Deviation 7.251
|
32.380 nanograms per milliliter (ng/mL)
Standard Deviation 17.181
|
21.200 nanograms per milliliter (ng/mL)
Standard Deviation 10.121
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Stage: Plasma Concentration of HMPL-689
0.5 hour post-dose: Day 28 Cycle 1
|
17.383 nanograms per milliliter (ng/mL)
Standard Deviation 22.271
|
101.100 nanograms per milliliter (ng/mL)
Standard Deviation 56.427
|
39.950 nanograms per milliliter (ng/mL)
Standard Deviation 37.487
|
67.000 nanograms per milliliter (ng/mL)
Standard Deviation 66.731
|
42.940 nanograms per milliliter (ng/mL)
Standard Deviation 18.447
|
24.367 nanograms per milliliter (ng/mL)
Standard Deviation 16.404
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Stage: Plasma Concentration of HMPL-689
1 hour post-dose: Day 28 Cycle 1
|
24.473 nanograms per milliliter (ng/mL)
Standard Deviation 29.361
|
110.300 nanograms per milliliter (ng/mL)
Standard Deviation 46.245
|
56.150 nanograms per milliliter (ng/mL)
Standard Deviation 51.474
|
113.333 nanograms per milliliter (ng/mL)
Standard Deviation 85.096
|
101.740 nanograms per milliliter (ng/mL)
Standard Deviation 64.018
|
140.533 nanograms per milliliter (ng/mL)
Standard Deviation 137.107
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Stage: Plasma Concentration of HMPL-689
2 hours post-dose: Day 28 Cycle 1
|
21.803 nanograms per milliliter (ng/mL)
Standard Deviation 15.134
|
61.550 nanograms per milliliter (ng/mL)
Standard Deviation 14.779
|
108.175 nanograms per milliliter (ng/mL)
Standard Deviation 39.401
|
126.500 nanograms per milliliter (ng/mL)
Standard Deviation 78.665
|
149.460 nanograms per milliliter (ng/mL)
Standard Deviation 74.134
|
219.250 nanograms per milliliter (ng/mL)
Standard Deviation 186.323
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Stage: Plasma Concentration of HMPL-689
4 hours post-dose: Day 28 Cycle 1
|
25.767 nanograms per milliliter (ng/mL)
Standard Deviation 2.050
|
55.750 nanograms per milliliter (ng/mL)
Standard Deviation 22.698
|
111.950 nanograms per milliliter (ng/mL)
Standard Deviation 33.596
|
115.000 nanograms per milliliter (ng/mL)
Standard Deviation 22.068
|
145.720 nanograms per milliliter (ng/mL)
Standard Deviation 57.106
|
133.333 nanograms per milliliter (ng/mL)
Standard Deviation 17.559
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Stage: Plasma Concentration of HMPL-689
8 hours post-dose: Day 28 Cycle 1
|
16.700 nanograms per milliliter (ng/mL)
Standard Deviation 3.341
|
32.700 nanograms per milliliter (ng/mL)
Standard Deviation 4.667
|
62.750 nanograms per milliliter (ng/mL)
Standard Deviation 21.418
|
66.867 nanograms per milliliter (ng/mL)
Standard Deviation 14.230
|
97.560 nanograms per milliliter (ng/mL)
Standard Deviation 29.737
|
81.533 nanograms per milliliter (ng/mL)
Standard Deviation 12.052
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Stage: Plasma Concentration of HMPL-689
Pre-dose: Day 1 Cycle 2
|
8.593 nanograms per milliliter (ng/mL)
Standard Deviation 4.588
|
17.500 nanograms per milliliter (ng/mL)
Standard Deviation 7.292
|
17.880 nanograms per milliliter (ng/mL)
Standard Deviation 7.265
|
19.200 nanograms per milliliter (ng/mL)
Standard Deviation 2.121
|
30.400 nanograms per milliliter (ng/mL)
Standard Deviation 13.557
|
16.833 nanograms per milliliter (ng/mL)
Standard Deviation 5.341
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 2, 15, 16, 28 of Cycle 1 and Day 1 of Cycle 2 (each cycle is 28 days)Population: The PKAS included all patients who received at least 1 dose of HMPL-689 and had at least 1 PK sample obtained and analyzed. Only patients with data collected at specified timepoints are reported.
Blood samples were collected to determine Ctrough of HMPL-689. The PK parameters were determined by non-compartmental analysis.
Outcome measures
| Measure |
Dose Escalation Stage: HMPL-689 5 mg QD
n=3 Participants
Patients received HMPL-689 5 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 10 mg QD
n=3 Participants
Patients received HMPL-689 10 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 15 mg QD
n=5 Participants
Patients received HMPL-689 15 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 20 mg QD
n=3 Participants
Patients received HMPL-689 20 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 25 mg QD
n=6 Participants
Patients received HMPL-689 25 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 30 mg QD
n=3 Participants
Patients received HMPL-689 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: CLL/SLL
Patients with CLL/SLL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: FL
Patients with FL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: MZL
Patient with MZL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: LPL/WM
Patients with LPL/WM received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: MCL
Patients with MCL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Stage: Plasma Trough Concentration (Ctrough) of HMPL-689
Day 2: Cycle 1
|
4.490 ng/mL
Standard Deviation 1.360
|
8.290 ng/mL
Standard Deviation 4.398
|
12.442 ng/mL
Standard Deviation 5.112
|
8.887 ng/mL
Standard Deviation 4.148
|
20.017 ng/mL
Standard Deviation 8.614
|
13.433 ng/mL
Standard Deviation 1.501
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Stage: Plasma Trough Concentration (Ctrough) of HMPL-689
Day 15: Cycle 1
|
4.580 ng/mL
Standard Deviation 0.521
|
35.613 ng/mL
Standard Deviation 39.872
|
16.600 ng/mL
Standard Deviation 6.678
|
16.650 ng/mL
Standard Deviation 4.031
|
31.160 ng/mL
Standard Deviation 15.418
|
22.900 ng/mL
Standard Deviation 11.077
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Stage: Plasma Trough Concentration (Ctrough) of HMPL-689
Day 16: Cycle 1
|
5.567 ng/mL
Standard Deviation 0.958
|
11.050 ng/mL
Standard Deviation 5.162
|
17.825 ng/mL
Standard Deviation 4.234
|
—
|
31.320 ng/mL
Standard Deviation 13.989
|
20.267 ng/mL
Standard Deviation 9.393
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Stage: Plasma Trough Concentration (Ctrough) of HMPL-689
Day 28: Cycle 1
|
5.837 ng/mL
Standard Deviation 1.257
|
10.885 ng/mL
Standard Deviation 1.860
|
19.575 ng/mL
Standard Deviation 9.215
|
25.133 ng/mL
Standard Deviation 7.251
|
32.380 ng/mL
Standard Deviation 17.181
|
21.200 ng/mL
Standard Deviation 10.121
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Stage: Plasma Trough Concentration (Ctrough) of HMPL-689
Day 1: Cycle 2
|
6.140 ng/mL
Standard Deviation 2.447
|
17.500 ng/mL
Standard Deviation 7.292
|
17.880 ng/mL
Standard Deviation 7.265
|
19.200 ng/mL
Standard Deviation 2.121
|
30.400 ng/mL
Standard Deviation 13.557
|
16.833 ng/mL
Standard Deviation 5.341
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 of Cycles 1, 2, 3, 5, 7, 9, 11, 13 and on Day 15 of Cycle 1; 0 hour on Day 1 of Cycle 1; 1, 2, 3, 4 hours post-dose on Days 1 and 15 of Cycle 1 (each cycle is 28 days)Population: The PKAS included all patients who received at least 1 dose of HMPL-689 and had at least 1 PK sample obtained and analyzed. Only patients with data collected at specified timepoints are reported.
Blood samples were collected to determine plasma concentration of HMPL-689. The PK parameters were determined by non-compartmental analysis.
Outcome measures
| Measure |
Dose Escalation Stage: HMPL-689 5 mg QD
n=3 Participants
Patients received HMPL-689 5 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 10 mg QD
n=13 Participants
Patients received HMPL-689 10 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 15 mg QD
n=6 Participants
Patients received HMPL-689 15 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 20 mg QD
n=3 Participants
Patients received HMPL-689 20 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 25 mg QD
n=5 Participants
Patients received HMPL-689 25 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 30 mg QD
Patients received HMPL-689 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: CLL/SLL
Patients with CLL/SLL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: FL
Patients with FL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: MZL
Patient with MZL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: LPL/WM
Patients with LPL/WM received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: MCL
Patients with MCL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Expansion Stage: Plasma Concentration of HMPL-689
Pre-dose: Day 1 Cycle 1
|
0.000 ng/mL
Standard Deviation 0.000
|
1.685 ng/mL
Standard Deviation 6.074
|
0.000 ng/mL
Standard Deviation 0.000
|
0.000 ng/mL
Standard Deviation 0.000
|
0.000 ng/mL
Standard Deviation 0.000
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Stage: Plasma Concentration of HMPL-689
0 hour post-dose: Day 1 Cycle 1
|
—
|
48.400 ng/mL
Standard Deviation 61.060
|
—
|
—
|
NA ng/mL
Standard Deviation NA
NA indicates that mean and standard deviation (SD) were not estimable for n\<3, as pre-specified in the statistical analysis plan (SAP).
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Stage: Plasma Concentration of HMPL-689
1 hour post-dose: Day 1 Cycle 1
|
54.743 ng/mL
Standard Deviation 85.161
|
108.857 ng/mL
Standard Deviation 74.766
|
145.600 ng/mL
Standard Deviation 131.539
|
86.950 ng/mL
Standard Deviation 93.589
|
75.750 ng/mL
Standard Deviation 33.441
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Stage: Plasma Concentration of HMPL-689
2 hours post-dose: Day 1 Cycle 1
|
104.233 ng/mL
Standard Deviation 117.306
|
150.523 ng/mL
Standard Deviation 51.261
|
171.000 ng/mL
Standard Deviation 71.632
|
136.333 ng/mL
Standard Deviation 114.031
|
132.460 ng/mL
Standard Deviation 27.338
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Stage: Plasma Concentration of HMPL-689
3 hours post-dose: Day 1 Cycle 1
|
101.967 ng/mL
Standard Deviation 70.324
|
130.742 ng/mL
Standard Deviation 54.780
|
131.600 ng/mL
Standard Deviation 33.368
|
98.267 ng/mL
Standard Deviation 70.926
|
116.667 ng/mL
Standard Deviation 11.930
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Stage: Plasma Concentration of HMPL-689
4 hours post-dose: Day 1 Cycle 1
|
111.833 ng/mL
Standard Deviation 22.661
|
117.708 ng/mL
Standard Deviation 62.408
|
108.833 ng/mL
Standard Deviation 30.521
|
72.933 ng/mL
Standard Deviation 37.302
|
119.720 ng/mL
Standard Deviation 36.898
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Stage: Plasma Concentration of HMPL-689
Pre-dose: Day 15 Cycle 1
|
22.933 ng/mL
Standard Deviation 8.804
|
37.056 ng/mL
Standard Deviation 22.923
|
31.363 ng/mL
Standard Deviation 25.923
|
16.667 ng/mL
Standard Deviation 16.220
|
115.880 ng/mL
Standard Deviation 147.709
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Stage: Plasma Concentration of HMPL-689
1 hour post-dose: Day 15 Cycle 1
|
142.967 ng/mL
Standard Deviation 119.865
|
146.358 ng/mL
Standard Deviation 92.001
|
125.917 ng/mL
Standard Deviation 52.229
|
95.467 ng/mL
Standard Deviation 66.718
|
180.800 ng/mL
Standard Deviation 87.697
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Stage: Plasma Concentration of HMPL-689
2 hours post-dose: Day 15 Cycle 1
|
233.667 ng/mL
Standard Deviation 2.082
|
193.417 ng/mL
Standard Deviation 92.573
|
167.433 ng/mL
Standard Deviation 71.148
|
128.000 ng/mL
Standard Deviation 88.705
|
190.400 ng/mL
Standard Deviation 53.003
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Stage: Plasma Concentration of HMPL-689
3 hours post-dose: Day 15 Cycle 1
|
179.000 ng/mL
Standard Deviation 30.447
|
166.550 ng/mL
Standard Deviation 65.746
|
140.867 ng/mL
Standard Deviation 56.317
|
95.333 ng/mL
Standard Deviation 38.783
|
165.000 ng/mL
Standard Deviation 75.024
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Stage: Plasma Concentration of HMPL-689
4 hours post-dose: Day 15 Cycle 1
|
140.667 ng/mL
Standard Deviation 48.003
|
148.333 ng/mL
Standard Deviation 44.252
|
123.483 ng/mL
Standard Deviation 48.346
|
85.167 ng/mL
Standard Deviation 35.335
|
153.520 ng/mL
Standard Deviation 46.202
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Stage: Plasma Concentration of HMPL-689
Pre-dose: Day 1 Cycle 2
|
NA ng/mL
Standard Deviation NA
NA indicates that mean and SD were not estimable for n\<3, as pre-specified in the SAP.
|
61.493 ng/mL
Standard Deviation 69.318
|
30.666 ng/mL
Standard Deviation 23.182
|
15.237 ng/mL
Standard Deviation 5.614
|
37.060 ng/mL
Standard Deviation 25.195
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Stage: Plasma Concentration of HMPL-689
Pre-dose: Day 1 Cycle 3
|
32.633 ng/mL
Standard Deviation 15.667
|
39.367 ng/mL
Standard Deviation 36.625
|
41.815 ng/mL
Standard Deviation 34.757
|
12.890 ng/mL
Standard Deviation 8.707
|
43.800 ng/mL
Standard Deviation 13.444
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Stage: Plasma Concentration of HMPL-689
Pre-dose: Day 1 Cycle 5
|
NA ng/mL
Standard Deviation NA
NA indicates that mean and SD were not estimable for n\<3, as pre-specified in the SAP.
|
82.100 ng/mL
Standard Deviation 55.917
|
40.412 ng/mL
Standard Deviation 40.658
|
NA ng/mL
Standard Deviation NA
NA indicates that mean and SD were not estimable for n\<3, as pre-specified in the SAP.
|
25.167 ng/mL
Standard Deviation 25.877
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Stage: Plasma Concentration of HMPL-689
Pre-dose: Day 1 Cycle 7
|
NA ng/mL
Standard Deviation NA
NA indicates that mean and SD were not estimable for n\<3, as pre-specified in the SAP.
|
NA ng/mL
Standard Deviation NA
NA indicates that mean and SD were not estimable for n\<3, as pre-specified in the SAP.
|
23.983 ng/mL
Standard Deviation 35.772
|
19.733 ng/mL
Standard Deviation 11.057
|
75.967 ng/mL
Standard Deviation 54.444
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Stage: Plasma Concentration of HMPL-689
Pre-dose: Day 1 Cycle 9
|
NA ng/mL
Standard Deviation NA
NA indicates that mean and SD were not estimable for n\<3, as pre-specified in the SAP.
|
49.400 ng/mL
Standard Deviation 46.088
|
NA ng/mL
Standard Deviation NA
NA indicates that mean and SD were not estimable for n\<3, as pre-specified in the SAP.
|
18.533 ng/mL
Standard Deviation 10.883
|
NA ng/mL
Standard Deviation NA
NA indicates that mean and SD were not estimable for n\<3, as pre-specified in the SAP.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Stage: Plasma Concentration of HMPL-689
Pre-dose: Day 1 Cycle 11
|
NA ng/mL
Standard Deviation NA
NA indicates that mean and SD were not estimable for n\<3, as pre-specified in the SAP.
|
NA ng/mL
Standard Deviation NA
NA indicates that mean and SD were not estimable for n\<3, as pre-specified in the SAP.
|
NA ng/mL
Standard Deviation NA
NA indicates that mean and SD were not estimable for n\<3, as pre-specified in the SAP.
|
NA ng/mL
Standard Deviation NA
NA indicates that mean and SD were not estimable for n\<3, as pre-specified in the SAP.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Stage: Plasma Concentration of HMPL-689
Pre-dose: Day 1 Cycle 13
|
—
|
NA ng/mL
Standard Deviation NA
NA indicates that mean and SD were not estimable for n\<3, as pre-specified in the SAP.
|
NA ng/mL
Standard Deviation NA
NA indicates that mean and SD were not estimable for n\<3, as pre-specified in the SAP.
|
NA ng/mL
Standard Deviation NA
NA indicates that mean and SD were not estimable for n\<3, as pre-specified in the SAP.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 of Cycles 1, 2, 3, 5, 7, 9, 11, 13 and on Day 15 of Cycle 1 (each cycle is 28 days)Population: The PKAS included all patients who received at least 1 dose of HMPL-689 and had at least 1 PK sample obtained and analyzed. Only patients with data collected at specified timepoints are reported.
Blood samples were collected to determine Ctrough of HMPL-689. The PK parameters were determined by non-compartmental analysis.
Outcome measures
| Measure |
Dose Escalation Stage: HMPL-689 5 mg QD
n=3 Participants
Patients received HMPL-689 5 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 10 mg QD
n=12 Participants
Patients received HMPL-689 10 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 15 mg QD
n=6 Participants
Patients received HMPL-689 15 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 20 mg QD
n=3 Participants
Patients received HMPL-689 20 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 25 mg QD
n=4 Participants
Patients received HMPL-689 25 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 30 mg QD
Patients received HMPL-689 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: CLL/SLL
Patients with CLL/SLL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: FL
Patients with FL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: MZL
Patient with MZL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: LPL/WM
Patients with LPL/WM received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: MCL
Patients with MCL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Expansion Stage: Plasma Trough Concentration of HMPL-689
Day 1: Cycle 1
|
—
|
21.900 ng/mL
Standard Deviation NA
NA indicates that SD could not be determined when only 1 patient was analyzed.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Stage: Plasma Trough Concentration of HMPL-689
Day 15: Cycle 1
|
22.933 ng/mL
Standard Deviation 8.804
|
37.056 ng/mL
Standard Deviation 22.923
|
31.363 ng/mL
Standard Deviation 25.923
|
16.667 ng/mL
Standard Deviation 16.220
|
132.125 ng/mL
Standard Deviation 165.321
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Stage: Plasma Trough Concentration of HMPL-689
Day 1: Cycle 2
|
24.550 ng/mL
Standard Deviation 2.758
|
41.013 ng/mL
Standard Deviation 36.989
|
30.666 ng/mL
Standard Deviation 23.182
|
15.237 ng/mL
Standard Deviation 5.614
|
46.325 ng/mL
Standard Deviation 16.555
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Stage: Plasma Trough Concentration of HMPL-689
Day 1: Cycle 3
|
23.750 ng/mL
Standard Deviation 4.172
|
46.214 ng/mL
Standard Deviation 38.254
|
33.587 ng/mL
Standard Deviation 37.495
|
14.390 ng/mL
Standard Deviation 11.752
|
43.800 ng/mL
Standard Deviation 13.444
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Stage: Plasma Trough Concentration of HMPL-689
Day 1: Cycle 5
|
36.450 ng/mL
Standard Deviation 15.627
|
63.625 ng/mL
Standard Deviation 43.513
|
49.225 ng/mL
Standard Deviation 41.065
|
18.150 ng/mL
Standard Deviation 11.102
|
25.167 ng/mL
Standard Deviation 25.877
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Stage: Plasma Trough Concentration of HMPL-689
Day 1: Cycle 7
|
34.050 ng/mL
Standard Deviation 6.293
|
27.950 ng/mL
Standard Deviation 9.829
|
32.550 ng/mL
Standard Deviation 46.033
|
22.850 ng/mL
Standard Deviation 13.647
|
75.967 ng/mL
Standard Deviation 54.444
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Stage: Plasma Trough Concentration of HMPL-689
Day 1: Cycle 9
|
37.400 ng/mL
Standard Deviation NA
NA indicates that SD could not be determined when only 1 patient was analyzed.
|
59.050 ng/mL
Standard Deviation 60.740
|
61.600 ng/mL
Standard Deviation NA
NA indicates that SD could not be determined when only 1 patient was analyzed.
|
18.533 ng/mL
Standard Deviation 10.883
|
28.950 ng/mL
Standard Deviation 4.596
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Stage: Plasma Trough Concentration of HMPL-689
Day 1: Cycle 11
|
28.100 ng/mL
Standard Deviation NA
NA indicates that SD could not be determined when only 1 patient was analyzed.
|
24.100 ng/mL
Standard Deviation NA
NA indicates that SD could not be determined when only 1 patient was analyzed.
|
65.200 ng/mL
Standard Deviation NA
NA indicates that SD could not be determined when only 1 patient was analyzed.
|
35.050 ng/mL
Standard Deviation 30.193
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Stage: Plasma Trough Concentration of HMPL-689
Day 1: Cycle 13
|
—
|
29.600 ng/mL
Standard Deviation NA
NA indicates that SD could not be determined when only 1 patient was analyzed.
|
18.800 ng/mL
Standard Deviation NA
NA indicates that SD could not be determined when only 1 patient was analyzed.
|
17.300 ng/mL
Standard Deviation NA
NA indicates that SD could not be determined when only 1 patient was analyzed.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 and 4 hours on Baseline (Day 1) of Cycle 1; 0, 2 and 4 hours on Day 15 of Cycle 1 (dose escalation phase); 1, 2, 3 and 4 hours on Baseline (Day 1) of Cycle 1; 0, 1, 2, 3, and 4 hours on Day 15 of Cycle 1 (dose expansion phase) (each cycle is 28 days)Population: The FAS included all patients who received at least 1 dose of HMPL-689. As pre-specified in the protocol, the results are presented by dose level and combined data for dose expansion stage is presented for all patients evaluable for this endpoint who received HMPL-689 at RP2D (30 mg QD) in dose expansion stage. Only patients with data collected at specified timepoints are reported.
12-lead electrocardiogram was performed to evaluate the effect of HMPL-689 on cardiac repolarization by detecting the changes in QTcF intervals. Baseline was defined as the last assessment performed prior to or on first non-zero dose date with time point marked as "pre-dose".
Outcome measures
| Measure |
Dose Escalation Stage: HMPL-689 5 mg QD
n=3 Participants
Patients received HMPL-689 5 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 10 mg QD
n=3 Participants
Patients received HMPL-689 10 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 15 mg QD
n=5 Participants
Patients received HMPL-689 15 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 20 mg QD
n=3 Participants
Patients received HMPL-689 20 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 25 mg QD
n=6 Participants
Patients received HMPL-689 25 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 30 mg QD
n=3 Participants
Patients received HMPL-689 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: CLL/SLL
n=30 Participants
Patients with CLL/SLL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: FL
Patients with FL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: MZL
Patient with MZL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: LPL/WM
Patients with LPL/WM received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: MCL
Patients with MCL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation and Dose Expansion Stages: Change From Baseline in Corrected QT Interval (QTc) Using Fridericia Formula (QTcF)
1 hour: Day 1 Cycle 1
|
—
|
—
|
—
|
—
|
—
|
—
|
-5.14 millisecond (msec)
Standard Deviation 10.6
|
—
|
—
|
—
|
—
|
|
Dose Escalation and Dose Expansion Stages: Change From Baseline in Corrected QT Interval (QTc) Using Fridericia Formula (QTcF)
2 hours: Day 1 Cycle 1
|
-6.89 millisecond (msec)
Standard Deviation 5.68
|
17.3 millisecond (msec)
Standard Deviation 0.471
|
-10.4 millisecond (msec)
Standard Deviation 7.51
|
-11.5 millisecond (msec)
Standard Deviation 9.19
|
-13.3 millisecond (msec)
Standard Deviation 13.5
|
-18.5 millisecond (msec)
Standard Deviation 2.59
|
-1.43 millisecond (msec)
Standard Deviation 9.80
|
—
|
—
|
—
|
—
|
|
Dose Escalation and Dose Expansion Stages: Change From Baseline in Corrected QT Interval (QTc) Using Fridericia Formula (QTcF)
3 hours: Day 1 Cycle 1
|
—
|
—
|
—
|
—
|
—
|
—
|
-2.21 millisecond (msec)
Standard Deviation 9.98
|
—
|
—
|
—
|
—
|
|
Dose Escalation and Dose Expansion Stages: Change From Baseline in Corrected QT Interval (QTc) Using Fridericia Formula (QTcF)
4 hours: Day 1 Cycle 1
|
-8.33 millisecond (msec)
Standard Deviation 7.00
|
9.67 millisecond (msec)
Standard Deviation 5.66
|
2.27 millisecond (msec)
Standard Deviation 13.6
|
6.11 millisecond (msec)
Standard Deviation 5.82
|
-9.33 millisecond (msec)
Standard Deviation 17.9
|
-10.7 millisecond (msec)
Standard Deviation 8.82
|
-2.46 millisecond (msec)
Standard Deviation 10.2
|
—
|
—
|
—
|
—
|
|
Dose Escalation and Dose Expansion Stages: Change From Baseline in Corrected QT Interval (QTc) Using Fridericia Formula (QTcF)
0 hour: Day 15 Cycle 1
|
-11.3 millisecond (msec)
Standard Deviation 21.7
|
-0.333 millisecond (msec)
Standard Deviation 8.49
|
-2.17 millisecond (msec)
Standard Deviation 8.72
|
-9.83 millisecond (msec)
Standard Deviation 2.59
|
-4.33 millisecond (msec)
Standard Deviation 13.6
|
-3.50 millisecond (msec)
Standard Deviation 4.01
|
0.231 millisecond (msec)
Standard Deviation 11.9
|
—
|
—
|
—
|
—
|
|
Dose Escalation and Dose Expansion Stages: Change From Baseline in Corrected QT Interval (QTc) Using Fridericia Formula (QTcF)
1 hour: Day 15 Cycle 1
|
—
|
—
|
—
|
—
|
—
|
—
|
2.11 millisecond (msec)
Standard Deviation 11.2
|
—
|
—
|
—
|
—
|
|
Dose Escalation and Dose Expansion Stages: Change From Baseline in Corrected QT Interval (QTc) Using Fridericia Formula (QTcF)
2 hours: Day 15 Cycle 1
|
-10.6 millisecond (msec)
Standard Deviation 7.70
|
1.50 millisecond (msec)
Standard Deviation 3.06
|
-0.583 millisecond (msec)
Standard Deviation 5.65
|
-7.22 millisecond (msec)
Standard Deviation 7.83
|
-10.0 millisecond (msec)
Standard Deviation 16.4
|
-14.8 millisecond (msec)
Standard Deviation 10.6
|
-0.524 millisecond (msec)
Standard Deviation 9.83
|
—
|
—
|
—
|
—
|
|
Dose Escalation and Dose Expansion Stages: Change From Baseline in Corrected QT Interval (QTc) Using Fridericia Formula (QTcF)
3 hours: Day 15 Cycle 1
|
—
|
—
|
—
|
—
|
—
|
—
|
0.614 millisecond (msec)
Standard Deviation 8.47
|
—
|
—
|
—
|
—
|
|
Dose Escalation and Dose Expansion Stages: Change From Baseline in Corrected QT Interval (QTc) Using Fridericia Formula (QTcF)
4 hours: Day 15 Cycle 1
|
-13.1 millisecond (msec)
Standard Deviation 12.1
|
6.67 millisecond (msec)
Standard Deviation 12.7
|
-2.17 millisecond (msec)
Standard Deviation 7.33
|
-9.11 millisecond (msec)
Standard Deviation 10.9
|
-4.27 millisecond (msec)
Standard Deviation 18.8
|
-11.0 millisecond (msec)
Standard Deviation 11.7
|
-0.964 millisecond (msec)
Standard Deviation 11.2
|
—
|
—
|
—
|
—
|
Adverse Events
Dose Escalation Stage: HMPL-689 5 mg QD
Dose Escalation Stage: HMPL-689 10 mg QD
Dose Escalation Stage: HMPL-689 15 mg QD
Dose Escalation Stage: HMPL-689 20 mg QD
Dose Escalation Stage: HMPL-689 25 mg QD
Dose Escalation Stage: HMPL-689 30 mg QD
Dose Expansion Stage: CLL/SLL
Dose Expansion Stage: FL
Dose Expansion Stage: MZL
Dose Expansion Stage: LPL/WM
Dose Expansion Stage: MCL
Serious adverse events
| Measure |
Dose Escalation Stage: HMPL-689 5 mg QD
n=3 participants at risk
Patients received HMPL-689 5 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 10 mg QD
n=3 participants at risk
Patients received HMPL-689 10 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 15 mg QD
n=5 participants at risk
Patients received HMPL-689 15 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 20 mg QD
n=3 participants at risk
Patients received HMPL-689 20 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 25 mg QD
n=6 participants at risk
Patients received HMPL-689 25 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 30 mg QD
n=3 participants at risk
Patients received HMPL-689 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: CLL/SLL
n=3 participants at risk
Patients with CLL/SLL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: FL
n=13 participants at risk
Patients with FL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: MZL
n=6 participants at risk
Patient with MZL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: LPL/WM
n=3 participants at risk
Patients with LPL/WM received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: MCL
n=5 participants at risk
Patients with MCL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
15.4%
2/13 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Infections and infestations
Cytomegalovirus infection reactivation
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
General disorders
Asthenia
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
General disorders
Disease progression
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Skin and subcutaneous tissue disorders
Cutaneous vasculitis
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
Other adverse events
| Measure |
Dose Escalation Stage: HMPL-689 5 mg QD
n=3 participants at risk
Patients received HMPL-689 5 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 10 mg QD
n=3 participants at risk
Patients received HMPL-689 10 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 15 mg QD
n=5 participants at risk
Patients received HMPL-689 15 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 20 mg QD
n=3 participants at risk
Patients received HMPL-689 20 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 25 mg QD
n=6 participants at risk
Patients received HMPL-689 25 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Escalation Stage: HMPL-689 30 mg QD
n=3 participants at risk
Patients received HMPL-689 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: CLL/SLL
n=3 participants at risk
Patients with CLL/SLL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: FL
n=13 participants at risk
Patients with FL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: MZL
n=6 participants at risk
Patient with MZL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: LPL/WM
n=3 participants at risk
Patients with LPL/WM received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
Dose Expansion Stage: MCL
n=5 participants at risk
Patients with MCL received HMPL-689 at RP2D, that is, 30 mg QD orally for continuous 28-day treatment cycles until PD, death, intolerable toxicity, investigator's assessment of no benefit from the study treatment, withdrawal from the study, or the end of study, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
60.0%
3/5 • Number of events 10 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
2/6 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 4 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
38.5%
5/13 • Number of events 6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
2/6 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
66.7%
2/3 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
30.8%
4/13 • Number of events 5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
15.4%
2/13 • Number of events 3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
15.4%
2/13 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
2/6 • Number of events 3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Gastrointestinal disorders
Swollen tongue
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Gastrointestinal disorders
Anal rash
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Gastrointestinal disorders
Oral disorder
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Gastrointestinal disorders
Saliva altered
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
30.8%
4/13 • Number of events 4 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
40.0%
2/5 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
40.0%
2/5 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
23.1%
3/13 • Number of events 5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
2/6 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 4 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
23.1%
3/13 • Number of events 7 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
15.4%
2/13 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Infections and infestations
Lyme disease
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Infections and infestations
Genital herpes simplex
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Infections and infestations
Tinea infection
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Skin and subcutaneous tissue disorders
Cutaneous vasculitis
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
2/6 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
33.3%
1/3 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
40.0%
2/5 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
23.1%
3/13 • Number of events 4 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
66.7%
2/3 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
23.1%
3/13 • Number of events 3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
40.0%
2/5 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
40.0%
2/5 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
38.5%
5/13 • Number of events 6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
15.4%
2/13 • Number of events 3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
15.4%
2/13 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
15.4%
2/13 • Number of events 3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
40.0%
2/5 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Investigations
White blood cell count increased
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Investigations
Lipase increased
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
2/6 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Investigations
Amylase increased
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Investigations
CD4 lymphocytes decreased
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Investigations
Liver function test increased
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Investigations
Transaminases increased
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
66.7%
2/3 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
30.8%
4/13 • Number of events 5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
23.1%
3/13 • Number of events 4 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
40.0%
2/5 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
23.1%
3/13 • Number of events 4 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
40.0%
2/5 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract inflammation
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchostenosis
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal haemorrhage
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
23.1%
3/13 • Number of events 3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
15.4%
2/13 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
General disorders
Fatigue
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
30.8%
4/13 • Number of events 4 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
40.0%
2/5 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
66.7%
2/3 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
23.1%
3/13 • Number of events 3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
2/6 • Number of events 4 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
General disorders
Asthenia
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
General disorders
Vaccination site pain
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
General disorders
General physical health deterioration
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
General disorders
Chills
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
General disorders
Facial pain
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
General disorders
Malaise
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
General disorders
Mass
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
General disorders
Peripheral swelling
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 4 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
23.1%
3/13 • Number of events 5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
2/6 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 2 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Eye disorders
Periorbital oedema
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Eye disorders
Retinopathy
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Eye disorders
Erythema of eyelid
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Immune system disorders
Jarisch-Herxheimer reaction
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 4 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Renal and urinary disorders
Leukocyturia
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenoma
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/6 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/13 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/3 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
0.00%
0/5 • AEs and SAEs were collected from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 34 months for dose escalation stage and 27 months for dose expansion stage. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1) up to 58 months.
Analysis was performed on the FAS.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place