Trial Outcomes & Findings for A Study of DSP-0509 in Patients With Advanced Solid Tumors to Determine the Safety and the Pharmacokinetic Profile (NCT NCT03416335)
NCT ID: NCT03416335
Last Updated: 2024-05-30
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
36 participants
Primary outcome timeframe
From the time of first dose to 6 weeks after the first dose
Results posted on
2024-05-30
Participant Flow
Thirty-six patients were enrolled into the Phase 1 (dose escalation) portion of this study. The study was terminated due to Sponsor's considerations, and therefore the MTD and RP2D have not been determined. No patients were enrolled into the Phase 2 (dose expansion) portion of the study.
Participants who progressed, died, withdrew consent to survival follow up or were lost to follow up were considered to have completed the study.
Participant milestones
| Measure |
Monotherapy Arm - Cohort 1
0.3mg of DSP-0509 monotherapy administered as an IV constant rate over 3 minutes weekly for 4 weeks followed by biweekly dosing.
|
Monotherapy Arm - Cohort 2
1.0mg of DSP-0509 monotherapy administered as an IV constant rate over 3 minutes weekly for 4 weeks followed by biweekly dosing.
|
Monotherapy Arm - Cohort 3
1.5mg of DSP-0509 monotherapy administered as an IV constant rate over 3 minutes weekly for 4 weeks followed by biweekly dosing.
|
Monotherapy Arm - Cohort 4
1.5mg of DSP-0509 monotherapy administered as an IV constant rate over 10 minutes every 2 weeks.
|
Monotherapy Arm - Cohort 5
2.4mg of DSP-0509 monotherapy administered as an IV constant rate over 10 minutes every 2 weeks.
|
Monotherapy Arm - Cohort 6
3.5mg of DSP-0509 monotherapy administered as an IV constant rate over 10 minutes every 2 weeks.
|
Combination Arm - Cohort 1
0.3mg DSP-0509 administered once weekly, with 200mg pembrolizumab administered once every 3 weeks
|
Combination Arm - Cohort 2
0.3mg DSP-0509 administered twice weekly, with 200mg pembrolizumab administered once every 3 weeks
|
Combination Arm - Cohort 3
1.0mg DSP-0509 administered twice weekly, with 200mg pembrolizumab administered once every 3 weeks
|
Combination Arm - Cohort 4
1.0mg DSP-0509 administered twice weekly, with 400mg pembrolizumab administered once every 6 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
5
|
3
|
4
|
7
|
1
|
3
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
4
|
5
|
3
|
4
|
7
|
1
|
3
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of DSP-0509 in Patients With Advanced Solid Tumors to Determine the Safety and the Pharmacokinetic Profile
Baseline characteristics by cohort
| Measure |
Monotherapy Arm - Cohort 1
n=3 Participants
0.3mg of DSP-0509 monotherapy administered as an IV constant rate over 3 minutes weekly for 4 weeks followed by biweekly dosing.
|
Monotherapy Arm - Cohort 2
n=4 Participants
1.0mg of DSP-0509 monotherapy administered as an IV constant rate over 3 minutes weekly for 4 weeks followed by biweekly dosing.
|
Monotherapy Arm - Cohort 3
n=5 Participants
1.5mg of DSP-0509 monotherapy administered as an IV constant rate over 3 minutes weekly for 4 weeks followed by biweekly dosing.
|
Monotherapy Arm - Cohort 4
n=3 Participants
1.5mg of DSP-0509 monotherapy administered as an IV constant rate over 10 minutes every 2 weeks.
|
Monotherapy Arm - Cohort 5
n=4 Participants
2.4mg of DSP-0509 monotherapy administered as an IV constant rate over 10 minutes every 2 weeks.
|
Monotherapy Arm - Cohort 6
n=7 Participants
3.5mg of DSP-0509 monotherapy administered as an IV constant rate over 10 minutes every 2 weeks.
|
Combination Arm - Cohort 1
n=1 Participants
0.3mg DSP-0509 administered once weekly, with 200mg pembrolizumab administered once every 3 weeks
|
Combination Arm - Cohort 2
n=3 Participants
0.3mg DSP-0509 administered twice weekly, with 200mg pembrolizumab administered once every 3 weeks
|
Combination Arm - Cohort 3
n=3 Participants
1.0mg DSP-0509 administered twice weekly, with 200mg pembrolizumab administered once every 3 weeks
|
Combination Arm - Cohort 4
n=3 Participants
1.0mg DSP-0509 administered twice weekly, with 400mg pembrolizumab administered once every 6 weeks
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
26 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
16 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
20 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
29 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: From the time of first dose to 6 weeks after the first doseOutcome measures
| Measure |
Monotherapy Arm - Cohort 1
n=3 Participants
0.3mg of DSP-0509 monotherapy administered as an IV constant rate over 3 minutes weekly for 4 weeks followed by biweekly dosing.
|
Monotherapy Arm - Cohort 2
n=4 Participants
1.0mg of DSP-0509 monotherapy administered as an IV constant rate over 3 minutes weekly for 4 weeks followed by biweekly dosing.
|
Monotherapy Arm - Cohort 3
n=5 Participants
1.5mg of DSP-0509 monotherapy administered as an IV constant rate over 3 minutes weekly for 4 weeks followed by biweekly dosing.
|
Monotherapy Arm - Cohort 4
n=3 Participants
1.5mg of DSP-0509 monotherapy administered as an IV constant rate over 10 minutes every 2 weeks.
|
Monotherapy Arm - Cohort 5
n=4 Participants
2.4mg of DSP-0509 monotherapy administered as an IV constant rate over 10 minutes every 2 weeks.
|
Monotherapy Arm - Cohort 6
n=7 Participants
3.5mg of DSP-0509 monotherapy administered as an IV constant rate over 10 minutes every 2 weeks.
|
Combination Arm - Cohort 1
n=1 Participants
0.3mg DSP-0509 administered once weekly, with 200mg pembrolizumab administered once every 3 weeks
|
Combination Arm - Cohort 2
n=3 Participants
0.3mg DSP-0509 administered twice weekly, with 200mg pembrolizumab administered once every 3 weeks
|
Combination Arm - Cohort 3
n=3 Participants
1.0mg DSP-0509 administered twice weekly, with 200mg pembrolizumab administered once every 3 weeks
|
Combination Arm - Cohort 4
n=3 Participants
1.0mg DSP-0509 administered twice weekly, with 400mg pembrolizumab administered once every 6 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose-limiting Toxicities (DLTs) Within the First 6 Weeks of Dosing
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: Sponsor's decision to terminate the study. Data were not collected to determine the RP2D.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 28 daysPopulation: Sponsor's decision to terminate the study. Data were not collected.
MTD of DSP-0509 in patients enrolled into the Combination Arm during the dose escalation part of the study.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 28 daysPopulation: Sponsor's decision to terminate the study. Data were not collected.
Data to be derived from patients enrolled into the Combination Arm - Part B (Phase 1).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 4 weeksPopulation: Sponsor's decision to terminate study. No patients were enrolled into phase 2 of the study.
Data to be derived from patients enrolled into the Combination Arm - Part C (Phase 2)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 weeksPopulation: Sponsor's decision to terminate study. Data were not collected.
Data to be derived from patients enrolled into the Monotherapy Arm - Part A (Phase 1)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From date of first dose to 6 months post first dosePopulation: Sponsor's decision to terminate study. Data were not collected.
Defined as the proportion of patients with a documented complete response or partial response (CR + PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From date of first dose to 6 months post first dosePopulation: Sponsor's decision to terminate study. Data were not collected.
Defined as the proportion of patients with a documented complete response or partial response (CR + PR) based on iRECIST.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: Sponsor's decision to terminate study. Data were not collected.
Defined as the time from first documentation of response until the time of first documentation of disease progression by RECIST v1.1.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: Sponsor's decision to terminate study. Data were not collected.
Defined as the time from first documentation of response until the time of first documentation of disease progression by iRECIST.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: Sponsor's decision to terminate study. Data were not collected.
Defined as the time from first dose to the earlier date of assessment of progression or death by any cause in the absence of progression by RECIST v1.1.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: Sponsor's decision to terminate study. Data were not collected.
Defined as the time from first dose to the earlier date of assessment of progression or death by any cause in the absence of progression by iRECIST.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 weeksPopulation: Sponsor's decision to terminate study. Data were not collected.
Data to be derived from patients enrolled into the Monotherapy Arm - Part A (Phase 1)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 weeksPopulation: Sponsor's decision to terminate study. Data were not collected.
Data to be derived from patients enrolled into the Combination Arm - Part B (Phase 1)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 weeksPopulation: Sponsor's decision to terminate study. Data were not collected.
Data to be derived from patients enrolled into the Combination Arm - Part B (Phase 1)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 8 weeksPopulation: Sponsor's decision to terminate study. Data were not collected.
Data to be derived from patients enrolled into the Monotherapy Arm - Part A (Phase 1)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: Sponsor's decision to terminate study. Data were not collected.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: Sponsor's decision to terminate study. Data were not collected.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: Sponsor's decision to terminate study. Data were not collected.
Data to be derived from patients enrolled into Monotherapy Arm - Part A (Phase 1)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: Sponsor's decision to terminate study. No patients were enrolled into Phase 2 of the study.
Data to be derived from patients enrolled into Combination Arm - Part C (Phase 2)
Outcome measures
Outcome data not reported
Adverse Events
Monotherapy Arm - Cohort 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Monotherapy Arm - Cohort 2
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Monotherapy Arm - Cohort 3
Serious events: 2 serious events
Other events: 5 other events
Deaths: 1 deaths
Monotherapy Arm - Cohort 4
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Monotherapy Arm - Cohort 5
Serious events: 1 serious events
Other events: 4 other events
Deaths: 1 deaths
Monotherapy Arm - Cohort 6
Serious events: 3 serious events
Other events: 7 other events
Deaths: 1 deaths
Combination Arm - Cohort 1
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Combination Arm - Cohort 2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Combination Arm - Cohort 3
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Combination Arm - Cohort 4
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Monotherapy Arm - Cohort 1
n=3 participants at risk
0.3mg of DSP-0509 monotherapy administered as an IV constant rate over 3 minutes weekly for 4 weeks followed by biweekly dosing.
|
Monotherapy Arm - Cohort 2
n=4 participants at risk
1.0mg of DSP-0509 monotherapy administered as an IV constant rate over 3 minutes weekly for 4 weeks followed by biweekly dosing.
|
Monotherapy Arm - Cohort 3
n=5 participants at risk
1.5mg of DSP-0509 monotherapy administered as an IV constant rate over 3 minutes weekly for 4 weeks followed by biweekly dosing.
|
Monotherapy Arm - Cohort 4
n=3 participants at risk
1.5mg of DSP-0509 monotherapy administered as an IV constant rate over 10 minutes every 2 weeks.
|
Monotherapy Arm - Cohort 5
n=4 participants at risk
2.4mg of DSP-0509 monotherapy administered as an IV constant rate over 10 minutes every 2 weeks.
|
Monotherapy Arm - Cohort 6
n=7 participants at risk
3.5mg of DSP-0509 monotherapy administered as an IV constant rate over 10 minutes every 2 weeks.
|
Combination Arm - Cohort 1
n=1 participants at risk
0.3mg DSP-0509 administered once weekly, with 200mg pembrolizumab administered once every 3 weeks
|
Combination Arm - Cohort 2
n=3 participants at risk
0.3mg DSP-0509 administered twice weekly, with 200mg pembrolizumab administered once every 3 weeks
|
Combination Arm - Cohort 3
n=3 participants at risk
1.0mg DSP-0509 administered twice weekly, with 200mg pembrolizumab administered once every 3 weeks
|
Combination Arm - Cohort 4
n=3 participants at risk
1.0mg DSP-0509 administered twice weekly, with 400mg pembrolizumab administered once every 6 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Eye disorders
Uveitis
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
100.0%
1/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
20.0%
1/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
General disorders
Disease progression
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
20.0%
1/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
General disorders
Generalised oedema
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
20.0%
1/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Immune system disorders
Cytokine release syndromes
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Infections and infestations
Encephalitis
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Infections and infestations
Urinary tract infections
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hemorrhage
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
20.0%
1/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
20.0%
1/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
Other adverse events
| Measure |
Monotherapy Arm - Cohort 1
n=3 participants at risk
0.3mg of DSP-0509 monotherapy administered as an IV constant rate over 3 minutes weekly for 4 weeks followed by biweekly dosing.
|
Monotherapy Arm - Cohort 2
n=4 participants at risk
1.0mg of DSP-0509 monotherapy administered as an IV constant rate over 3 minutes weekly for 4 weeks followed by biweekly dosing.
|
Monotherapy Arm - Cohort 3
n=5 participants at risk
1.5mg of DSP-0509 monotherapy administered as an IV constant rate over 3 minutes weekly for 4 weeks followed by biweekly dosing.
|
Monotherapy Arm - Cohort 4
n=3 participants at risk
1.5mg of DSP-0509 monotherapy administered as an IV constant rate over 10 minutes every 2 weeks.
|
Monotherapy Arm - Cohort 5
n=4 participants at risk
2.4mg of DSP-0509 monotherapy administered as an IV constant rate over 10 minutes every 2 weeks.
|
Monotherapy Arm - Cohort 6
n=7 participants at risk
3.5mg of DSP-0509 monotherapy administered as an IV constant rate over 10 minutes every 2 weeks.
|
Combination Arm - Cohort 1
n=1 participants at risk
0.3mg DSP-0509 administered once weekly, with 200mg pembrolizumab administered once every 3 weeks
|
Combination Arm - Cohort 2
n=3 participants at risk
0.3mg DSP-0509 administered twice weekly, with 200mg pembrolizumab administered once every 3 weeks
|
Combination Arm - Cohort 3
n=3 participants at risk
1.0mg DSP-0509 administered twice weekly, with 200mg pembrolizumab administered once every 3 weeks
|
Combination Arm - Cohort 4
n=3 participants at risk
1.0mg DSP-0509 administered twice weekly, with 400mg pembrolizumab administered once every 6 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
80.0%
4/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
75.0%
3/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
42.9%
3/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
20.0%
1/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
100.0%
1/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
50.0%
2/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
20.0%
1/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Ear and labyrinth disorders
Excessive cerumen production
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Eye disorders
Blurred vision
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
100.0%
1/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Eye disorders
Cataract
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Eye disorders
Eye pain
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
100.0%
1/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Eye disorders
Optic nerve disorder
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Eye disorders
Trichiasis
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Eye disorders
Uveitis
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
100.0%
1/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Eye disorders
Vitreous floaters
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
60.0%
3/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
50.0%
2/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
28.6%
2/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
40.0%
2/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
40.0%
2/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
50.0%
2/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
40.0%
2/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
100.0%
1/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
40.0%
2/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
100.0%
1/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
50.0%
2/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
20.0%
1/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
General disorders
Fatigue
|
66.7%
2/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
60.0%
3/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
66.7%
2/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
75.0%
3/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
28.6%
2/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
100.0%
1/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
66.7%
2/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
General disorders
Malaise
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
40.0%
2/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
General disorders
Pyrexia
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
20.0%
1/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
General disorders
Disease progression
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
20.0%
1/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
General disorders
Peripheral swelling
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
General disorders
Swelling
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
General disorders
Chills
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
General disorders
Facial pain
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
100.0%
1/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
General disorders
Generalized oedema
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
20.0%
1/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
General disorders
Localised oedema
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
20.0%
1/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Infections and infestations
Encephalitis
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Infections and infestations
Wound infection
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
20.0%
1/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
50.0%
2/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Investigations
Amylase increased
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
100.0%
1/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
20.0%
1/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Investigations
Weight decreased
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
20.0%
1/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Investigations
Protein urine present
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
20.0%
1/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
50.0%
2/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
100.0%
1/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
20.0%
1/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Investigations
Blood calcium increased
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Investigations
Blood creatinine phosphokinase increased
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Investigations
Blood phosphorous increased
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
20.0%
1/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Investigations
White blood cell count increased
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
66.7%
2/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
50.0%
2/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
20.0%
1/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
20.0%
1/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
20.0%
1/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
40.0%
2/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
100.0%
1/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
40.0%
2/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
20.0%
1/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
20.0%
1/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
20.0%
1/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
66.7%
2/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeleton pain
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
100.0%
1/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
100.0%
1/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
66.7%
2/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Nervous system disorders
Dysgeusia
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Nervous system disorders
Aura
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Psychiatric disorders
Anxiety
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
20.0%
1/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
100.0%
1/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
20.0%
1/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Renal and urinary disorders
Urine abnormality
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
40.0%
2/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
28.6%
2/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
20.0%
1/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea exertional
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal oedema
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
20.0%
1/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
20.0%
1/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
66.7%
2/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
50.0%
2/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
50.0%
2/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
100.0%
1/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
20.0%
1/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Vascular disorders
Hot Flush
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
25.0%
1/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/5 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/4 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/1 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
33.3%
1/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
0.00%
0/3 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.
Analysis of patients enrolled into each dose cohort during the dose escalation was not done; therefore no data are available for reporting. The outcome reported is based on the totality of AEs and SAEs reported in each arm during phase 1 of the study. No patients were enrolled into phase 2 of the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place