Trial Outcomes & Findings for Gemtuzumab Ozogamicin With G-CSF, Cladribine, Cytarabine & Mitoxantrone for Untreated AML & High-Grade Myeloid Neoplasm (NCT NCT03531918)
NCT ID: NCT03531918
Last Updated: 2023-08-30
Results Overview
Defined as the highest dose studied in which the incidence of Dose Limiting Toxicity (DLT) is ≤33% (≤4 of 12 patients experiencing DLT), defined as any Grade 3 non-hematologic toxicity lasting \>48 hours that results in \>7-day delay of the subsequent treatment cycle, with the exception of febrile neutropenia or infection or toxicities secondary to febrile neutropenia or infection, or any Grade ≥4 non-hematologic toxicity except febrile neutropenia/infection (or toxicities secondary to febrile neutropenia or infection) unless felt to be a direct consequence of treatment-related toxicity (e.g. intestinal infection following mucosal barrier breakdown), and with the exception of constitutional symptoms if recovery to Grade ≤2 within 14 days. The National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 will be used.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
66 participants
Primary outcome timeframe
At time of count recovery, second cycle of treatment, response assessment or removal from protocol (at approximately 1 month).
Results posted on
2023-08-30
Participant Flow
Participant milestones
| Measure |
GO1 Dose Level Phase 1
Participants received 1 dose of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on day 1.
All doses of GO were capped at 4.5 mg.
|
GO3 Dose Level Includes Phase 1 and Phase 2
Phase 1: Participants received 3 doses of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on days 1, 4, and 7.
Phase 2: Participants received CLAG-M(cladribine, high-dose cytarabine, G-CSF and dose-escalated mitoxantrone)/GO at the recommended phase 2 dose (RP2D) identified in phase 1.
All doses of GO were capped at 4.5 mg.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
60
|
|
Overall Study
COMPLETED
|
6
|
56
|
|
Overall Study
NOT COMPLETED
|
0
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gemtuzumab Ozogamicin With G-CSF, Cladribine, Cytarabine & Mitoxantrone for Untreated AML & High-Grade Myeloid Neoplasm
Baseline characteristics by cohort
| Measure |
GO1 Dose Level Phase 1
n=6 Participants
Participants received 1 dose of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on day 1.
All doses of GO were capped at 4.5 mg.
|
GO3 Dose Level Includes Phase 1 and Phase 2
n=60 Participants
Phase 1: Participants received 3 doses of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on days 1, 4, and 7.
Phase 2: Participants received CLAG-M(cladribine, high-dose cytarabine, G-CSF and dose-escalated mitoxantrone)/GO at the recommended phase 2 dose (RP2D) identified in phase 1.
All doses of GO were capped at 4.5 mg.
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Age, Continuous
|
64.83 years
n=5 Participants
|
61.13 years
n=7 Participants
|
61.47 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
60 participants
n=7 Participants
|
66 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At time of count recovery, second cycle of treatment, response assessment or removal from protocol (at approximately 1 month).Defined as the highest dose studied in which the incidence of Dose Limiting Toxicity (DLT) is ≤33% (≤4 of 12 patients experiencing DLT), defined as any Grade 3 non-hematologic toxicity lasting \>48 hours that results in \>7-day delay of the subsequent treatment cycle, with the exception of febrile neutropenia or infection or toxicities secondary to febrile neutropenia or infection, or any Grade ≥4 non-hematologic toxicity except febrile neutropenia/infection (or toxicities secondary to febrile neutropenia or infection) unless felt to be a direct consequence of treatment-related toxicity (e.g. intestinal infection following mucosal barrier breakdown), and with the exception of constitutional symptoms if recovery to Grade ≤2 within 14 days. The National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 will be used.
Outcome measures
| Measure |
GO1 Dose Level Phase 1
n=6 Participants
Participants received 1 dose of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on day 1.
All doses of GO were capped at 4.5 mg.
|
GO3 Dose Level Includes Phase 1 and Phase 2
n=60 Participants
Phase 1: Participants received 3 doses of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on days 1, 4, and 7.
Phase 2: Participants received CLAG-M(cladribine, high-dose cytarabine, G-CSF and dose-escalated mitoxantrone)/GO at the recommended phase 2 dose (RP2D) identified in phase 1.
All doses of GO were capped at 4.5 mg.
|
|---|---|---|
|
Maximum Tolerated Dose (MTD) of Gemtuzumab Ozogamicin (GO) When Added to GCLAM (Phase 1)
|
NA Participants
The Maximum Tolerated Dose was not reached since the GO3 dose level (the maximum dose specified by the protocol) had a dose-limiting toxicity rate of greater than 33%. Thusly, the GO3 dose level is the recommended phase 2 dose but not the MTD.
|
NA Participants
The Maximum Tolerated Dose was not reached since the GO3 dose level (the maximum dose specified by the protocol) had a dose-limiting toxicity rate of greater than 33%. Thusly, the GO3 dose level is the recommended phase 2 dose but not the MTD.
|
PRIMARY outcome
Timeframe: From the start of study treatment, assessed at 6 months and 1 yearPopulation: GO1 participants were treated in dose escalation. The primary endpoint per protocol is to assess the EFS rate at the MTD or RP2D and was not assessed at dose levels below the RP2D.
A two-stage design will be used to evaluate the EFS. Patients treated at the maximum tolerated dose (MTD) from the phase 1 portion of the trial will be used in the phase 2 analysis. If censoring occurs, secondary analyses analyzing 6-month or 1-year EFS accounting for censoring will be done, including estimating 6-month or 1-year EFS using the Kaplan-Meier method. The first stage of the two-stage phase 2 design will evaluate 30 patients. If 20 or more of the first 30 patients are alive without event at 6-months after study registration, an additional 30 patients will be enrolled. If 46 or more of the 60 patients treated at the MTD are alive and without event at 6-months after study registration, the study will consider the regimen of interest for further investigation. Patients last known to be alive in CR were censored at date of last contact.
Outcome measures
| Measure |
GO1 Dose Level Phase 1
Participants received 1 dose of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on day 1.
All doses of GO were capped at 4.5 mg.
|
GO3 Dose Level Includes Phase 1 and Phase 2
n=60 Participants
Phase 1: Participants received 3 doses of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on days 1, 4, and 7.
Phase 2: Participants received CLAG-M(cladribine, high-dose cytarabine, G-CSF and dose-escalated mitoxantrone)/GO at the recommended phase 2 dose (RP2D) identified in phase 1.
All doses of GO were capped at 4.5 mg.
|
|---|---|---|
|
Event-free Survival (EFS) Rate (Phase 2)
Event-free Survival (6 months)
|
—
|
73 percent of participants
Interval 63.0 to 85.0
|
|
Event-free Survival (EFS) Rate (Phase 2)
Event-free survival (12 months)
|
—
|
58 percent of participants
Interval 47.0 to 72.0
|
SECONDARY outcome
Timeframe: Up to 5 years. 30-day all-cause mortality is reportedPopulation: 30-day mortality is reported among patients treated at the MTD/RP2D. There is no study-related reason to report survival data on the GO1 dose level. No efficacy assessments were evaluated during the GO1 phase 1 dose escalation study which focuses on DLT/toxicity assessments.
As a summary of adverse events (captured on trial using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0), 30-day all cause mortality is reported as a percent of patients treated at the MTD/RP2D. Will be estimated and 95% confidence intervals will be calculated. Regression models (logistic regression for binary endpoints, Cox regression for time-to-event endpoints \[Cox models for the hazard of the subdistribution for events with competing risks\]) will be used to compare outcomes with patients who have received GCLAM without GO at our institution, controlling for measured prognostic factors.
Outcome measures
| Measure |
GO1 Dose Level Phase 1
Participants received 1 dose of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on day 1.
All doses of GO were capped at 4.5 mg.
|
GO3 Dose Level Includes Phase 1 and Phase 2
n=60 Participants
Phase 1: Participants received 3 doses of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on days 1, 4, and 7.
Phase 2: Participants received CLAG-M(cladribine, high-dose cytarabine, G-CSF and dose-escalated mitoxantrone)/GO at the recommended phase 2 dose (RP2D) identified in phase 1.
All doses of GO were capped at 4.5 mg.
|
|---|---|---|
|
30-day All-cause Mortality
|
—
|
.03 proportion died on/before day 30
Interval 0.0004 to 0.12
|
SECONDARY outcome
Timeframe: Up to 5 years. 2-year RFS reported.Population: RFS is reported among patients treated at the MTD/RP2D. There is no study-related reason to report survival data on the GO1 dose level. No efficacy assessments were evaluated during the GO 1 phase 1 dose escalation study which focuses on DLT/toxicity assessments.
RFS was calculated for participants who achieved a complete remission (with or without count recovery; CR or CRi) and measured from the date remission to the first of relapse from CR/CRi or death from any cause. Patients last known to be alive in CR /CRi were censored at date of last contact. Will be estimated using the Kaplan-Meier method. Time to relapse will be estimated using non-parametric estimates of the cumulative incidence curve with death analyzed as a competing event. Regression models (logistic regression for binary endpoints, Cox regression for time-to-event endpoints \[Cox models for the hazard of the subdistribution for events with competing risks\]) will be used to compare outcomes with patients who have received GCLAM without GO at our institution, controlling for measured prognostic factors.
Outcome measures
| Measure |
GO1 Dose Level Phase 1
Participants received 1 dose of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on day 1.
All doses of GO were capped at 4.5 mg.
|
GO3 Dose Level Includes Phase 1 and Phase 2
n=52 Participants
Phase 1: Participants received 3 doses of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on days 1, 4, and 7.
Phase 2: Participants received CLAG-M(cladribine, high-dose cytarabine, G-CSF and dose-escalated mitoxantrone)/GO at the recommended phase 2 dose (RP2D) identified in phase 1.
All doses of GO were capped at 4.5 mg.
|
|---|---|---|
|
Relapse-free Survival of GO3 Cohort
|
—
|
51 percentage of participants
Interval 34.0 to 64.0
|
SECONDARY outcome
Timeframe: 3 years and 1 monthPopulation: RFS is reported among patients treated at the MTD/RP2D. There is no study-related reason to report survival data on the GO1 dose level. No efficacy assessments were evaluated during the GO1 phase 1 dose escalation study which focuses on DLT/toxicity assessments.
OS was calculated for all participants and measured from initial trial therapy to death from any cause. Patients last known ot be alive were censored at date of last contact. Will be estimated using the Kaplan-Meier method. Regression models (logistic regression for binary endpoints, Cox regression for time-to-event endpoints \[Cox models for the hazard of the subdistribution for events with competing risks\]) will be used to compare outcomes with patients who have received GCLAM without GO at our institution, controlling for measured prognostic factors.
Outcome measures
| Measure |
GO1 Dose Level Phase 1
Participants received 1 dose of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on day 1.
All doses of GO were capped at 4.5 mg.
|
GO3 Dose Level Includes Phase 1 and Phase 2
n=60 Participants
Phase 1: Participants received 3 doses of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on days 1, 4, and 7.
Phase 2: Participants received CLAG-M(cladribine, high-dose cytarabine, G-CSF and dose-escalated mitoxantrone)/GO at the recommended phase 2 dose (RP2D) identified in phase 1.
All doses of GO were capped at 4.5 mg.
|
|---|---|---|
|
Overall Survival
|
—
|
60 percentage of participants
Interval 48.0 to 73.0
|
SECONDARY outcome
Timeframe: 90 daysWill be estimated and 95% confidence intervals will be calculated. Regression models (logistic regression for binary endpoints, Cox regression for time-to-event endpoints \[Cox models for the hazard of the subdistribution for events with competing risks\]) will be used to compare outcomes with patients who have received GCLAM without GO at our institution, controlling for measured prognostic factors. Complete response (CR) rate is defined as the frequency of patients achieving CR, which is defined by the European LeukemiaNet 2017 guidelines as bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC ≥1.0 x 109/L (1000/mL); platelet count ≥100 x 109/L. (100 000/mL). MRD negative (MRDneg) status is defined as negative for leukemic markers by multiparameter flow cytometry. Aplasia was defined as absence of tumoral cells but cellularity not meeting criteria for MLFS. Statistical significance tests were not performed.
Outcome measures
| Measure |
GO1 Dose Level Phase 1
n=6 Participants
Participants received 1 dose of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on day 1.
All doses of GO were capped at 4.5 mg.
|
GO3 Dose Level Includes Phase 1 and Phase 2
n=60 Participants
Phase 1: Participants received 3 doses of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on days 1, 4, and 7.
Phase 2: Participants received CLAG-M(cladribine, high-dose cytarabine, G-CSF and dose-escalated mitoxantrone)/GO at the recommended phase 2 dose (RP2D) identified in phase 1.
All doses of GO were capped at 4.5 mg.
|
|---|---|---|
|
Measurable Residual Disease (MRD) Rates and Remission Rates: CR
MRDneg
|
4 Participants
|
38 Participants
|
|
Measurable Residual Disease (MRD) Rates and Remission Rates: CR
MRDpos
|
0 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 90 daysWill be estimated and 95% confidence intervals will be calculated. Regression models (logistic regression for binary endpoints, Cox regression for time-to-event endpoints \[Cox models for the hazard of the subdistribution for events with competing risks\]) will be used to compare outcomes with patients who have received GCLAM without GO at our institution, controlling for measured prognostic factors. Complete response with incomplete hematologic recovery (CRi) rate is defined as the frequency of patients achieving CRi, which is defined by the European LeukemiaNet 2017 guidelines as all CR criteria except for residual neutropenia (ANC \<1.0 x 109/L \[1000/mL\]) or thrombocytopenia (platelet count \<100 x 109/L \[100,000/mL\]). MRD negative (MRDneg) status is defined as negative for leukemic markers by multiparameter flow cytometry. Aplasia was defined as absence of tumoral cells but cellularity not meeting criteria for MLFS. Statistical significance tests were not performed.
Outcome measures
| Measure |
GO1 Dose Level Phase 1
n=6 Participants
Participants received 1 dose of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on day 1.
All doses of GO were capped at 4.5 mg.
|
GO3 Dose Level Includes Phase 1 and Phase 2
n=60 Participants
Phase 1: Participants received 3 doses of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on days 1, 4, and 7.
Phase 2: Participants received CLAG-M(cladribine, high-dose cytarabine, G-CSF and dose-escalated mitoxantrone)/GO at the recommended phase 2 dose (RP2D) identified in phase 1.
All doses of GO were capped at 4.5 mg.
|
|---|---|---|
|
Measurable Residual Disease (MRD) and Remission Rates: CRi (MRDneg)
|
1 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 90 daysPopulation: GO1: remission rates for 6 patients: CR rate was 4/6, CR+CRi rate was 5/6 (all MRDneg)
Will be estimated and 95% confidence intervals will be calculated. Regression models (logistic regression for binary endpoints, Cox regression for time-to-event endpoints \[Cox models for the hazard of the subdistribution for events with competing risks\]) will be used to compare outcomes with patients who have received GCLAM without GO at our institution, controlling for measured prognostic factors. Complete response (CR) + complete response with incomplete hematologic recovery (CRi) rate is defined as the frequency of patients achieving CR or CRi per the European LeukemiaNet 2017 criteria as defined above. MRD negative (MRDneg) status is defined as negative for leukemic markers by multiparameter flow cytometry. Aplasia was defined as absence of tumoral cells but cellularity not meeting criteria for MLFS. Statistical significance tests were not performed.
Outcome measures
| Measure |
GO1 Dose Level Phase 1
n=6 Participants
Participants received 1 dose of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on day 1.
All doses of GO were capped at 4.5 mg.
|
GO3 Dose Level Includes Phase 1 and Phase 2
n=60 Participants
Phase 1: Participants received 3 doses of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on days 1, 4, and 7.
Phase 2: Participants received CLAG-M(cladribine, high-dose cytarabine, G-CSF and dose-escalated mitoxantrone)/GO at the recommended phase 2 dose (RP2D) identified in phase 1.
All doses of GO were capped at 4.5 mg.
|
|---|---|---|
|
Measurable Residual Disease (MRD) and Remission Rates: CR/CRi
|
5 Participants
|
52 Participants
|
SECONDARY outcome
Timeframe: 90 daysWill be estimated and 95% confidence intervals will be calculated. Regression models (logistic regression for binary endpoints, Cox regression for time-to-event endpoints \[Cox models for the hazard of the subdistribution for events with competing risks\]) will be used to compare outcomes with patients who have received GCLAM without GO at our institution, controlling for measured prognostic factors. Morphologic leukemia free state (MLFS) rate is defined as the frequency of patients achieving MLFS, which is defined by the European LeukemiaNet guidelines as bone marrow blasts \<5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required. At least 200 cells should be enumerated or cellularity should be at least 10%. MRD negative (MRDneg) status is defined as negative for leukemic markers by multiparameter flow cytometry. Aplasia was defined as absence of tumoral cells but cellularity not meeting criteria for MLFS. Statistical significance
Outcome measures
| Measure |
GO1 Dose Level Phase 1
n=6 Participants
Participants received 1 dose of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on day 1.
All doses of GO were capped at 4.5 mg.
|
GO3 Dose Level Includes Phase 1 and Phase 2
n=60 Participants
Phase 1: Participants received 3 doses of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on days 1, 4, and 7.
Phase 2: Participants received CLAG-M(cladribine, high-dose cytarabine, G-CSF and dose-escalated mitoxantrone)/GO at the recommended phase 2 dose (RP2D) identified in phase 1.
All doses of GO were capped at 4.5 mg.
|
|---|---|---|
|
Measurable Residual Disease (MRD) and Remission Rates: MLFS (MRDneg)
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 90 daysWill be estimated and 95% confidence intervals will be calculated. Regression models (logistic regression for binary endpoints, Cox regression for time-to-event endpoints \[Cox models for the hazard of the subdistribution for events with competing risks\]) will be used to compare outcomes with patients who have received GCLAM without GO at our institution, controlling for measured prognostic factors. o Aplasia rate is defined in this protocol as frequency of patients without blood count recovery after chemotherapy and bone marrow examination showing hypocellularity not meeting cellularity criteria for morphologic leukemia free state (MLFS). MRD negative (MRDneg) status is defined as negative for leukemic markers by multiparameter flow cytometry. Aplasia was defined as absence of tumoral cells but cellularity not meeting criteria for MLFS. Statistical significance tests were not performed.
Outcome measures
| Measure |
GO1 Dose Level Phase 1
n=6 Participants
Participants received 1 dose of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on day 1.
All doses of GO were capped at 4.5 mg.
|
GO3 Dose Level Includes Phase 1 and Phase 2
n=60 Participants
Phase 1: Participants received 3 doses of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on days 1, 4, and 7.
Phase 2: Participants received CLAG-M(cladribine, high-dose cytarabine, G-CSF and dose-escalated mitoxantrone)/GO at the recommended phase 2 dose (RP2D) identified in phase 1.
All doses of GO were capped at 4.5 mg.
|
|---|---|---|
|
Measurable Residual Disease (MRD) and Remission Rates: Alapasia (MRDneg)
|
0 Participants
|
2 Participants
|
Adverse Events
GO1 Dose Level Phase 1
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
GO3 Dose Level Includes Phase 1 and Phase 2
Serious events: 10 serious events
Other events: 59 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
GO1 Dose Level Phase 1
n=6 participants at risk
Participants received 1 dose of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on day 1.
All doses of GO were capped at 4.5 mg.
|
GO3 Dose Level Includes Phase 1 and Phase 2
n=60 participants at risk
Phase 1: Participants received 3 doses of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on days 1, 4, and 7.
Phase 2: Participants received CLAG-M(cladribine, high-dose cytarabine, G-CSF and dose-escalated mitoxantrone)/GO at the recommended phase 2 dose (RP2D) identified in phase 1.
All doses of GO were capped at 4.5 mg.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Grade 4 Bronchopulmonary Hemorrhage
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
1.7%
1/60 • Number of events 2 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Cardiac disorders
Grade 3 Left Ventricular Systolic Dysfunction
|
16.7%
1/6 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
0.00%
0/60 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Investigations
Grade 4 Aspartate Aminotransferase Increase
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
1.7%
1/60 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Nervous system disorders
Grade 3 Reversible Posterior Leukoencephalopathy Syndrome
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
1.7%
1/60 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Nervous system disorders
Grade 3 Intercranial Hemorrhage
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
3.3%
2/60 • Number of events 2 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Nervous system disorders
Grade 3 Ataxia
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
1.7%
1/60 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Metabolism and nutrition disorders
Grade 4 Tumor Lysis
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
1.7%
1/60 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Cardiac disorders
Grade 3 Pericardial Effusion
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
1.7%
1/60 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Injury, poisoning and procedural complications
Grade 3 Hip Fracture
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
1.7%
1/60 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Gastrointestinal disorders
Grade 4 Upper Gastrointestinal Hemorrhage
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
1.7%
1/60 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Infections and infestations
Grade 3 Encephalitis Infection
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
1.7%
1/60 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Nervous system disorders
Grade 3 Stroke
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
1.7%
1/60 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Respiratory, thoracic and mediastinal disorders
Grade 4 Hypoxia
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
1.7%
1/60 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Respiratory, thoracic and mediastinal disorders
Grade 4 Respiratory Failure
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
3.3%
2/60 • Number of events 2 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Cardiac disorders
Grade 4 Cardiac Arrest
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
1.7%
1/60 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
Other adverse events
| Measure |
GO1 Dose Level Phase 1
n=6 participants at risk
Participants received 1 dose of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on day 1.
All doses of GO were capped at 4.5 mg.
|
GO3 Dose Level Includes Phase 1 and Phase 2
n=60 participants at risk
Phase 1: Participants received 3 doses of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on days 1, 4, and 7.
Phase 2: Participants received CLAG-M(cladribine, high-dose cytarabine, G-CSF and dose-escalated mitoxantrone)/GO at the recommended phase 2 dose (RP2D) identified in phase 1.
All doses of GO were capped at 4.5 mg.
|
|---|---|---|
|
Blood and lymphatic system disorders
Grade 3 Febrile Neutropenia
|
16.7%
1/6 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
93.3%
56/60 • Number of events 88 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Gastrointestinal disorders
Grade 3 Esophageal Hemorrhage
|
16.7%
1/6 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
0.00%
0/60 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Infections and infestations
Grade 3 Bacteremia
|
16.7%
1/6 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
0.00%
0/60 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Gastrointestinal disorders
Grade 3 Enterocolitis
|
33.3%
2/6 • Number of events 2 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
3.3%
2/60 • Number of events 2 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Cardiac disorders
Grade 3 Chest Pain - Cardiac
|
16.7%
1/6 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
0.00%
0/60 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Infections and infestations
Grade 3 Sepsis
|
33.3%
2/6 • Number of events 2 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
46.7%
28/60 • Number of events 28 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Infections and infestations
Grade 4 Sepsis
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
5.0%
3/60 • Number of events 4 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Cardiac disorders
Grade 3 Hypotension
|
16.7%
1/6 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
1.7%
1/60 • Number of events 2 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Vascular disorders
Grade 3 Hypertension
|
16.7%
1/6 • Number of events 2 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
61.7%
37/60 • Number of events 79 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Infections and infestations
Grade 3 Skin Infection
|
16.7%
1/6 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
5.0%
3/60 • Number of events 3 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Nervous system disorders
Grade 3 Headache
|
16.7%
1/6 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
0.00%
0/60 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Infections and infestations
Grade 3 Lung Infection
|
16.7%
1/6 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
11.7%
7/60 • Number of events 9 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Reproductive system and breast disorders
Grade 3 Perineal Pain
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
1.7%
1/60 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Reproductive system and breast disorders
Grade 3 Vaginal Hemorrhage
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
1.7%
1/60 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Gastrointestinal disorders
Grade 3 Diarrhea
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
1.7%
1/60 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Investigations
Grade 3 Alanine Aminotransferase Increase
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
3.3%
2/60 • Number of events 2 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Metabolism and nutrition disorders
Grade 3 Hypokalemia
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
6.7%
4/60 • Number of events 4 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Metabolism and nutrition disorders
Grade 4 Hypokalemia
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
1.7%
1/60 • Number of events 2 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Metabolism and nutrition disorders
Grade 3 Tumor Lysis Syndrome
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
8.3%
5/60 • Number of events 5 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Gastrointestinal disorders
Grade 3 Upper Gastrointestinal Hemorrhage
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
6.7%
4/60 • Number of events 4 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Gastrointestinal disorders
Grade 3 Lower Gastrointestinal Hemorrhage
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
5.0%
3/60 • Number of events 3 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Respiratory, thoracic and mediastinal disorders
Grade 3 Epistaxis
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
1.7%
1/60 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Blood and lymphatic system disorders
Grade 3 Disseminated Intravascular Coagulation
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
8.3%
5/60 • Number of events 5 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Infections and infestations
Grade 3 Urinary Tract Infection
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
3.3%
2/60 • Number of events 2 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Nervous system disorders
Grade 3 Intracranial Hemorrhage
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
1.7%
1/60 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Investigations
Grade 3 Aspartate Aminotransferase Increase
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
6.7%
4/60 • Number of events 4 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Infections and infestations
Grade 3 Hepatic Infection
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
1.7%
1/60 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Gastrointestinal disorders
Grade 3 Typhlitis
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
1.7%
1/60 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Cardiac disorders
Grade 3 Left Ventricular Systolic Dysfunction
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
8.3%
5/60 • Number of events 5 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Investigations
Grade 3 Ejection Fraction Decrease
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
1.7%
1/60 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Gastrointestinal disorders
Grade 3 Vomiting
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
1.7%
1/60 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Respiratory, thoracic and mediastinal disorders
Grade 3 Pulmonary Edema
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
11.7%
7/60 • Number of events 7 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Cardiac disorders
Grade 3 Atrial Fibrillation
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
5.0%
3/60 • Number of events 4 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Cardiac disorders
Grade 3 Myocardial Infarction
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
3.3%
2/60 • Number of events 2 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Renal and urinary disorders
Grade 3 Acute Kidney Injury
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
1.7%
1/60 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Renal and urinary disorders
Grade 4 Acute Kidney Injury
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
1.7%
1/60 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Renal and urinary disorders
Grade 3 Hematuria
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
3.3%
2/60 • Number of events 2 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Metabolism and nutrition disorders
Grade 3 Hyperglycemia
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
10.0%
6/60 • Number of events 6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Nervous system disorders
Grade 3 Dysarthria
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
1.7%
1/60 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Gastrointestinal disorders
Grade 3 Esophagitis
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
3.3%
2/60 • Number of events 2 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Gastrointestinal disorders
Grade 3 Mucositis Oral
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
5.0%
3/60 • Number of events 3 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Metabolism and nutrition disorders
Grade 3 Hypocalcemia
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
3.3%
2/60 • Number of events 2 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Respiratory, thoracic and mediastinal disorders
Grade 3 Hypoxia
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
8.3%
5/60 • Number of events 5 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Respiratory, thoracic and mediastinal disorders
Grade 4 Hypoxia
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
1.7%
1/60 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Metabolism and nutrition disorders
Grade 3 Hyperphosphatemia
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
1.7%
1/60 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Musculoskeletal and connective tissue disorders
Grade 3 Pain in extremity
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
1.7%
1/60 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Gastrointestinal disorders
Grade 3 Constipation
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
1.7%
1/60 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Cardiac disorders
Grade 3 Heart Failure
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
1.7%
1/60 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Nervous system disorders
Grade 3 Syncope
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
1.7%
1/60 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
General disorders
Grade 3 Generalized Edema
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
1.7%
1/60 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Infections and infestations
Grade 3 Catheter Related Infection
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
5.0%
3/60 • Number of events 3 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Skin and subcutaneous tissue disorders
Grade 3 Rash Maculo-papular
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
1.7%
1/60 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Gastrointestinal disorders
Grade 3 Dysphagia
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
3.3%
2/60 • Number of events 2 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Metabolism and nutrition disorders
Grade 3 Acidosis
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
1.7%
1/60 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Nervous system disorders
Grade 3 Encephalopathy
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
1.7%
1/60 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Metabolism and nutrition disorders
Grade 3 Hypernatremia
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
1.7%
1/60 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Metabolism and nutrition disorders
Grade 4 Hypernatremia
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
1.7%
1/60 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Metabolism and nutrition disorders
Grade 3 Anorexia
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
1.7%
1/60 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Respiratory, thoracic and mediastinal disorders
Grade 3 Dyspnea
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
1.7%
1/60 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Infections and infestations
Grade 3 Shingles
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
1.7%
1/60 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Respiratory, thoracic and mediastinal disorders
Grade 3 Bronchopulmonary Hemorrhage
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
1.7%
1/60 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Gastrointestinal disorders
Grade 3 Dental Caries
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
1.7%
1/60 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Gastrointestinal disorders
Grade 3 Colonic Perforation
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
1.7%
1/60 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Gastrointestinal disorders
Grade 3 Colonic Hemorrhage
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
1.7%
1/60 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Metabolism and nutrition disorders
Grade 3 Hypophosphatemia
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
1.7%
1/60 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Infections and infestations
Grade 3 Anorectal Infection
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
1.7%
1/60 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Blood and lymphatic system disorders
Grade 3 Menorrhagia
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
1.7%
1/60 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
|
Musculoskeletal and connective tissue disorders
Grade 3 Arthritis
|
0.00%
0/6 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
1.7%
1/60 • Number of events 1 • Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.
Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.
|
Additional Information
Roland Walter, Member of Clinical Research Division
Fred Hutchinson Cancer Center
Phone: 206-667-3599
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place