Trial Outcomes & Findings for Nivolumab Plus Ipilimumab in Thyroid Cancer (NCT NCT03246958)
NCT ID: NCT03246958
Last Updated: 2025-06-19
Results Overview
Best overall response rate is defined as the percentage of participants who achieved Complete response (CR) or partial response (PR) on treatment based on RECIST 1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
53 participants
Primary outcome timeframe
Median (range) treatment duration (days) of 163.0 (21.0-734.0) for DTC cohort, for MTC cohort was 58.0 (30.0-252.0), and for ATC cohort 135.5 (10.0-735.0).
Results posted on
2025-06-19
Participant Flow
Patients enrolled from October 2017 to July 2019.
Per protocol order in sequential design was not expected to impact efficacy rather was for exploratory correlative analyses.
Participant milestones
| Measure |
DTC - Nivolumab Alone for Two Weeks
Differentiated Thyroid Cancer (DTC) participants received Ipilimumab 1mg/kg q6 weeks via IV infusion, starting two weeks after Nivolumab 3mg/kg q6 weeks.
|
DTC - Ipilimumab Alone for Two Weeks
Differentiated Thyroid Cancer (DTC) participants received Nivolumab 3mg/kg q6 weeks via IV infusion, starting two weeks after Ipilimumab 1mg/kg q6 weeks.
|
MTC - Nivolumab Alone for Two Week
Medullary Thyroid Cancer (MTC) participants received Ipilimumab 1mg/kg q6 weeks via IV infusion, starting two weeks after Nivolumab 3mg/kg q6 weeks.
|
MTC - Ipilimumab Alone for Two Weeks
Medullary Thyroid Cancer (MTC) participants received Nivolumab 3mg/kg q6 weeks via IV infusion, starting two weeks after Ipilimumab 1mg/kg q6 weeks.
|
ATC - Nivolumab Alone for Two Week
Anaplastic Thyroid Cancer (ATC) received Ipilimumab 1mg/kg q6 weeks via IV infusion, starting two weeks after Nivolumab 3mg/kg q6 weeks.
|
ATC - Ipilimumab Alone for Two Week
Anaplastic Thyroid Cancer (ATC) received Nivolumab 3mg/kg q6 weeks via IV infusion, starting two weeks after Ipilimumab 1mg/kg q6 weeks.
|
ATC - Ipilimumab + Nivolumab
Anaplastic Thyroid Cancer (ATC) received Nivolumab 3mg/kg q6 weeks and Ipilimumab 1mg/kg q6 weeks via IV infusion.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
17
|
18
|
3
|
4
|
2
|
4
|
4
|
|
Overall Study
Analyzable
|
16
|
16
|
3
|
4
|
2
|
4
|
4
|
|
Overall Study
COMPLETED
|
1
|
3
|
0
|
0
|
0
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
16
|
15
|
3
|
4
|
2
|
3
|
3
|
Reasons for withdrawal
| Measure |
DTC - Nivolumab Alone for Two Weeks
Differentiated Thyroid Cancer (DTC) participants received Ipilimumab 1mg/kg q6 weeks via IV infusion, starting two weeks after Nivolumab 3mg/kg q6 weeks.
|
DTC - Ipilimumab Alone for Two Weeks
Differentiated Thyroid Cancer (DTC) participants received Nivolumab 3mg/kg q6 weeks via IV infusion, starting two weeks after Ipilimumab 1mg/kg q6 weeks.
|
MTC - Nivolumab Alone for Two Week
Medullary Thyroid Cancer (MTC) participants received Ipilimumab 1mg/kg q6 weeks via IV infusion, starting two weeks after Nivolumab 3mg/kg q6 weeks.
|
MTC - Ipilimumab Alone for Two Weeks
Medullary Thyroid Cancer (MTC) participants received Nivolumab 3mg/kg q6 weeks via IV infusion, starting two weeks after Ipilimumab 1mg/kg q6 weeks.
|
ATC - Nivolumab Alone for Two Week
Anaplastic Thyroid Cancer (ATC) received Ipilimumab 1mg/kg q6 weeks via IV infusion, starting two weeks after Nivolumab 3mg/kg q6 weeks.
|
ATC - Ipilimumab Alone for Two Week
Anaplastic Thyroid Cancer (ATC) received Nivolumab 3mg/kg q6 weeks via IV infusion, starting two weeks after Ipilimumab 1mg/kg q6 weeks.
|
ATC - Ipilimumab + Nivolumab
Anaplastic Thyroid Cancer (ATC) received Nivolumab 3mg/kg q6 weeks and Ipilimumab 1mg/kg q6 weeks via IV infusion.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Progression
|
13
|
9
|
3
|
2
|
1
|
2
|
1
|
|
Overall Study
Adverse Event
|
2
|
2
|
0
|
1
|
1
|
0
|
2
|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Never start treatment
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Over enrollment
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Nivolumab Plus Ipilimumab in Thyroid Cancer
Baseline characteristics by cohort
| Measure |
DTC - Nivolumab Alone for Two Weeks
n=16 Participants
Differentiated Thyroid Cancer (DTC) participants received Ipilimumab 1mg/kg q6 weeks via IV infusion, starting two weeks after Nivolumab 3mg/kg q6 weeks.
|
DTC - Ipilimumab Alone for Two Weeks
n=16 Participants
Differentiated Thyroid Cancer (DTC) participants received Nivolumab 3mg/kg q6 weeks via IV infusion, starting two weeks after Ipilimumab 1mg/kg q6 weeks.
|
MTC - Nivolumab Alone for Two Week
n=3 Participants
Medullary Thyroid Cancer (MTC)participants received Ipilimumab 1mg/kg q6 weeks via IV infusion, starting two weeks after Nivolumab 3mg/kg q6 weeks.
|
MTC - Ipilimumab Alone for Two Weeks
n=4 Participants
Medullary Thyroid Cancer (MTC) participants received Nivolumab 3mg/kg q6 weeks via IV infusion, starting two weeks after Ipilimumab 1mg/kg q6 weeks.
|
ATC - Nivolumab Alone for Two Week
n=2 Participants
Anaplastic Thyroid Cancer (ATC) received Ipilimumab 1mg/kg q6 weeks via IV infusion, starting two weeks after Nivolumab 3mg/kg q6 weeks.
|
ATC - Ipilimumab Alone for Two Week
n=4 Participants
Anaplastic Thyroid Cancer (ATC) received Nivolumab 3mg/kg q6 weeks via IV infusion, starting two weeks after Ipilimumab 1mg/kg q6 weeks.
|
ATC - Ipilimumab + Nivolumab
n=4 Participants
Anaplastic Thyroid Cancer (ATC) received Nivolumab 3mg/kg q6 weeks and Ipilimumab 1mg/kg q6 weeks via IV infusion.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
ECOG Performance Status
1
|
9 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
31 Participants
n=6 Participants
|
|
Age, Continuous
|
64.9 Years
STANDARD_DEVIATION 11.8 • n=99 Participants
|
63.4 Years
STANDARD_DEVIATION 10.3 • n=107 Participants
|
54.7 Years
STANDARD_DEVIATION 2.9 • n=206 Participants
|
51.8 Years
STANDARD_DEVIATION 16.3 • n=7 Participants
|
51.4 Years
STANDARD_DEVIATION 2.1 • n=31 Participants
|
69.3 Years
STANDARD_DEVIATION 16.9 • n=30 Participants
|
58.4 Years
STANDARD_DEVIATION 8.3 • n=3 Participants
|
62.1 Years
STANDARD_DEVIATION 11.9 • n=6 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
25 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
24 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
46 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
White
|
15 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
20 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
25 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
|
ECOG Performance Status
0
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
17 Participants
n=6 Participants
|
|
ECOG Performance Status
2
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Median (range) treatment duration (days) of 163.0 (21.0-734.0) for DTC cohort, for MTC cohort was 58.0 (30.0-252.0), and for ATC cohort 135.5 (10.0-735.0).Population: It was pre-specified in the Study Protocol to report data by disease cohort irrespective of assigned treatment sequence.
Best overall response rate is defined as the percentage of participants who achieved Complete response (CR) or partial response (PR) on treatment based on RECIST 1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
Outcome measures
| Measure |
Differentiated Thyroid Cancer (Primary Cohort)
n=32 Participants
Differentiated Thyroid Cancer (DTC) participants received Ipilimumab (Ipi) 1mg/kg q6 weeks and Nivolumab (Nivo) 3mg/kg q6 weeks sequentially either Ipi or Nivo first with 2 weeks apart prior to start of either Ipi or Nivo second.
Participants were treated indefinitely until disease progression or withdrawal for other reasons.
|
Medullary Thyroid Cancer (Exploratory Cohort)
n=7 Participants
Medullary Thyroid Cancer (MTC) participants received Ipilimumab (Ipi) 1mg/kg q6 weeks and Nivolumab (Nivo) 3mg/kg q6 weeks sequentially either Ipi or Nivo first with 2 weeks apart prior to start of either Ipi or Nivo second.
Participants were treated indefinitely until disease progression or withdrawal for other reasons.
|
Anaplastic Thyroid Cancer (Exploratory Cohort)
n=10 Participants
Anaplastic Thyroid Cancer (ATC) participants received Ipilimumab (Ipi) 1mg/kg q6 weeks and Nivolumab (Nivo) 3mg/kg q6 weeks sequentially either Ipi or Nivo first with 2 weeks apart prior to start of either Ipi or Nivo second prior to study amendment or in combination from the start after study amendment due to aggressive nature of the disease in this cohort.
Participants were treated indefinitely until disease progression or withdrawal for other reasons.
|
|---|---|---|---|
|
Best Overall Response Rate
|
9.4 percentage of participants
Interval 2.8 to 28.5
|
0 percentage of participants
Interval 0.0 to 41.0
|
30 percentage of participants
Interval 6.7 to 65.2
|
SECONDARY outcome
Timeframe: Median (range) follow-up (months) for DTC cohort was 24.0 (1.84 - 24.7), for MTC cohort was 24.0 (23.0-24.2), and for ATC cohort was 22.2 (0.46 - 26.1).Population: It was pre-specified in the Study Protocol to report data by disease cohort irrespective of assigned treatment sequence.
Progression-Free Survival (PFS) based on Kaplan-Meier methodology is defined as the time from randomization (or registration) to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation. Participants alive without PD were censored at the earliest of the date of the last disease evaluation or start of new anticancer therapy. Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated.
Outcome measures
| Measure |
Differentiated Thyroid Cancer (Primary Cohort)
n=32 Participants
Differentiated Thyroid Cancer (DTC) participants received Ipilimumab (Ipi) 1mg/kg q6 weeks and Nivolumab (Nivo) 3mg/kg q6 weeks sequentially either Ipi or Nivo first with 2 weeks apart prior to start of either Ipi or Nivo second.
Participants were treated indefinitely until disease progression or withdrawal for other reasons.
|
Medullary Thyroid Cancer (Exploratory Cohort)
n=7 Participants
Medullary Thyroid Cancer (MTC) participants received Ipilimumab (Ipi) 1mg/kg q6 weeks and Nivolumab (Nivo) 3mg/kg q6 weeks sequentially either Ipi or Nivo first with 2 weeks apart prior to start of either Ipi or Nivo second.
Participants were treated indefinitely until disease progression or withdrawal for other reasons.
|
Anaplastic Thyroid Cancer (Exploratory Cohort)
n=10 Participants
Anaplastic Thyroid Cancer (ATC) participants received Ipilimumab (Ipi) 1mg/kg q6 weeks and Nivolumab (Nivo) 3mg/kg q6 weeks sequentially either Ipi or Nivo first with 2 weeks apart prior to start of either Ipi or Nivo second prior to study amendment or in combination from the start after study amendment due to aggressive nature of the disease in this cohort.
Participants were treated indefinitely until disease progression or withdrawal for other reasons.
|
|---|---|---|---|
|
Median Progression Free Survival
|
7.11 Months
Interval 2.07 to 17.02
|
2.14 Months
Interval 0.92 to 3.98
|
4.29 Months
Interval 0.46 to
NA due to limited number of events.
|
SECONDARY outcome
Timeframe: Median (range) follow-up (months) for DTC cohort was 24.0 (1.84 - 24.7), for MTC cohort was 24.0 (23.0-24.2), and for ATC cohort was 22.2 (0.46 - 26.1).Population: It was pre-specified in the Study Protocol to report data by disease cohort irrespective of assigned treatment sequence.
Overall Survival is the percent probability estimate at 2 years based on Kaplan-Meier methodology. OS is defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive.
Outcome measures
| Measure |
Differentiated Thyroid Cancer (Primary Cohort)
n=32 Participants
Differentiated Thyroid Cancer (DTC) participants received Ipilimumab (Ipi) 1mg/kg q6 weeks and Nivolumab (Nivo) 3mg/kg q6 weeks sequentially either Ipi or Nivo first with 2 weeks apart prior to start of either Ipi or Nivo second.
Participants were treated indefinitely until disease progression or withdrawal for other reasons.
|
Medullary Thyroid Cancer (Exploratory Cohort)
n=7 Participants
Medullary Thyroid Cancer (MTC) participants received Ipilimumab (Ipi) 1mg/kg q6 weeks and Nivolumab (Nivo) 3mg/kg q6 weeks sequentially either Ipi or Nivo first with 2 weeks apart prior to start of either Ipi or Nivo second.
Participants were treated indefinitely until disease progression or withdrawal for other reasons.
|
Anaplastic Thyroid Cancer (Exploratory Cohort)
n=10 Participants
Anaplastic Thyroid Cancer (ATC) participants received Ipilimumab (Ipi) 1mg/kg q6 weeks and Nivolumab (Nivo) 3mg/kg q6 weeks sequentially either Ipi or Nivo first with 2 weeks apart prior to start of either Ipi or Nivo second prior to study amendment or in combination from the start after study amendment due to aggressive nature of the disease in this cohort.
Participants were treated indefinitely until disease progression or withdrawal for other reasons.
|
|---|---|---|---|
|
Overall Survival at 2 Years (OS2)
|
77.2 Percent Probability
Interval 58.1 to 88.5
|
85.7 Percent Probability
Interval 33.4 to 97.9
|
55.6 Percent Probability
Interval 20.4 to 80.5
|
SECONDARY outcome
Timeframe: AEs were assessed every two weeks on treatment and within 30 days after the last dose. Median (range) treatment duration (days) of 163.0 (21.0-734.0) for DTC cohort, for MTC cohort was 58.0 (30.0-252.0), and for ATC cohort 135.5 (10.0-735.0).Population: It was pre-specified in the Study Protocol to report data by disease cohort irrespective of assigned treatment sequence.
Treatment-related adverse events rate was defined as the proportion of participants who experienced an adverse event with treatment attribution of possible, probable or definite, including all grades based on the Common Toxicity Criteria for Adverse Events Version 4.0 (CTCAEv4) as reported on case report forms.
Outcome measures
| Measure |
Differentiated Thyroid Cancer (Primary Cohort)
n=32 Participants
Differentiated Thyroid Cancer (DTC) participants received Ipilimumab (Ipi) 1mg/kg q6 weeks and Nivolumab (Nivo) 3mg/kg q6 weeks sequentially either Ipi or Nivo first with 2 weeks apart prior to start of either Ipi or Nivo second.
Participants were treated indefinitely until disease progression or withdrawal for other reasons.
|
Medullary Thyroid Cancer (Exploratory Cohort)
n=7 Participants
Medullary Thyroid Cancer (MTC) participants received Ipilimumab (Ipi) 1mg/kg q6 weeks and Nivolumab (Nivo) 3mg/kg q6 weeks sequentially either Ipi or Nivo first with 2 weeks apart prior to start of either Ipi or Nivo second.
Participants were treated indefinitely until disease progression or withdrawal for other reasons.
|
Anaplastic Thyroid Cancer (Exploratory Cohort)
n=10 Participants
Anaplastic Thyroid Cancer (ATC) participants received Ipilimumab (Ipi) 1mg/kg q6 weeks and Nivolumab (Nivo) 3mg/kg q6 weeks sequentially either Ipi or Nivo first with 2 weeks apart prior to start of either Ipi or Nivo second prior to study amendment or in combination from the start after study amendment due to aggressive nature of the disease in this cohort.
Participants were treated indefinitely until disease progression or withdrawal for other reasons.
|
|---|---|---|---|
|
Treatment-Related Adverse Events Rate
|
0.81 proportion of participants
Interval 0.64 to 0.93
|
1 proportion of participants
Interval 0.59 to 1.0
|
0.80 proportion of participants
Interval 0.44 to 0.97
|
Adverse Events
DTC - Nivolumab Alone for Two Weeks
Serious events: 5 serious events
Other events: 16 other events
Deaths: 5 deaths
DTC - Ipilimumab Alone for Two Weeks
Serious events: 3 serious events
Other events: 16 other events
Deaths: 5 deaths
MTC - Nivolumab Alone for Two Week
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
MTC - Ipilimumab Alone for Two Weeks
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
ATC - Nivolumab Alone for Two Week
Serious events: 2 serious events
Other events: 2 other events
Deaths: 1 deaths
ATC - Ipilimumab Alone for Two Week
Serious events: 2 serious events
Other events: 4 other events
Deaths: 2 deaths
ATC - Ipilimumab + Nivolumab
Serious events: 0 serious events
Other events: 4 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
DTC - Nivolumab Alone for Two Weeks
n=16 participants at risk
Differentiated Thyroid Cancer (DTC) participants received Ipilimumab 1mg/kg q6 weeks via IV infusion, starting two weeks after Nivolumab 3mg/kg q6 weeks.
|
DTC - Ipilimumab Alone for Two Weeks
n=16 participants at risk
Differentiated Thyroid Cancer (DTC) participants received Nivolumab 3mg/kg q6 weeks via IV infusion, starting two weeks after Ipilimumab 1mg/kg q6 weeks.
|
MTC - Nivolumab Alone for Two Week
n=3 participants at risk
Medullary Thyroid Cancer (MTC) participants received Ipilimumab 1mg/kg q6 weeks via IV infusion, starting two weeks after Nivolumab 3mg/kg q6 weeks.
|
MTC - Ipilimumab Alone for Two Weeks
n=4 participants at risk
Medullary Thyroid Cancer (MTC) participants received Nivolumab 3mg/kg q6 weeks via IV infusion, starting two weeks after Ipilimumab 1mg/kg q6 weeks.
|
ATC - Nivolumab Alone for Two Week
n=2 participants at risk
Anaplastic Thyroid Cancer (ATC) received Ipilimumab 1mg/kg q6 weeks via IV infusion, starting two weeks after Nivolumab 3mg/kg q6 weeks.
|
ATC - Ipilimumab Alone for Two Week
n=4 participants at risk
Anaplastic Thyroid Cancer (ATC) received Nivolumab 3mg/kg q6 weeks via IV infusion, starting two weeks after Ipilimumab 1mg/kg q6 weeks.
|
ATC - Ipilimumab + Nivolumab
n=4 participants at risk
Anaplastic Thyroid Cancer (ATC) received Nivolumab 3mg/kg q6 weeks and Ipilimumab 1mg/kg q6 weeks via IV infusion.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
33.3%
1/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Gastrointestinal disorders
Colitis
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
General disorders
Pain
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
50.0%
1/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Infections and infestations
Lung infection
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Injury, poisoning and procedural complications
Fall
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Injury, poisoning and procedural complications
Tracheostomy site bleeding
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Investigations
Alanine aminotransferase increased
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Investigations
Lipase increased
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Nervous system disorders
Syncope
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
12.5%
2/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
50.0%
1/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
100.0%
2/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
Other adverse events
| Measure |
DTC - Nivolumab Alone for Two Weeks
n=16 participants at risk
Differentiated Thyroid Cancer (DTC) participants received Ipilimumab 1mg/kg q6 weeks via IV infusion, starting two weeks after Nivolumab 3mg/kg q6 weeks.
|
DTC - Ipilimumab Alone for Two Weeks
n=16 participants at risk
Differentiated Thyroid Cancer (DTC) participants received Nivolumab 3mg/kg q6 weeks via IV infusion, starting two weeks after Ipilimumab 1mg/kg q6 weeks.
|
MTC - Nivolumab Alone for Two Week
n=3 participants at risk
Medullary Thyroid Cancer (MTC) participants received Ipilimumab 1mg/kg q6 weeks via IV infusion, starting two weeks after Nivolumab 3mg/kg q6 weeks.
|
MTC - Ipilimumab Alone for Two Weeks
n=4 participants at risk
Medullary Thyroid Cancer (MTC) participants received Nivolumab 3mg/kg q6 weeks via IV infusion, starting two weeks after Ipilimumab 1mg/kg q6 weeks.
|
ATC - Nivolumab Alone for Two Week
n=2 participants at risk
Anaplastic Thyroid Cancer (ATC) received Ipilimumab 1mg/kg q6 weeks via IV infusion, starting two weeks after Nivolumab 3mg/kg q6 weeks.
|
ATC - Ipilimumab Alone for Two Week
n=4 participants at risk
Anaplastic Thyroid Cancer (ATC) received Nivolumab 3mg/kg q6 weeks via IV infusion, starting two weeks after Ipilimumab 1mg/kg q6 weeks.
|
ATC - Ipilimumab + Nivolumab
n=4 participants at risk
Anaplastic Thyroid Cancer (ATC) received Nivolumab 3mg/kg q6 weeks and Ipilimumab 1mg/kg q6 weeks via IV infusion.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
12.5%
2/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
12.5%
2/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
50.0%
1/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
12.5%
2/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
12.5%
2/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Cardiac disorders
Chest pain - cardiac
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Cardiac disorders
Sinus tachycardia
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Ear and labyrinth disorders
Ear pain
|
12.5%
2/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
12.5%
2/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
50.0%
1/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Ear and labyrinth disorders
Vertigo
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Endocrine disorders
Adrenal insufficiency
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Endocrine disorders
Hyperthyroidism
|
12.5%
2/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
12.5%
2/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Endocrine disorders
Hypothyroidism
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Eye disorders
Blurred vision
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Eye disorders
Conjunctivitis
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Eye disorders
Dry eye
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Eye disorders
Eye pain
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Eye disorders
Retinal tear
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
50.0%
1/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
31.2%
5/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
31.2%
5/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
66.7%
2/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
50.0%
1/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Gastrointestinal disorders
Bloating
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
50.0%
2/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Gastrointestinal disorders
Constipation
|
12.5%
2/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
12.5%
2/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
50.0%
1/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Gastrointestinal disorders
Diarrhea
|
43.8%
7/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
43.8%
7/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
33.3%
1/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
50.0%
2/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
75.0%
3/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Gastrointestinal disorders
Dysphagia
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
50.0%
1/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
33.3%
1/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Gastrointestinal disorders
Mucositis oral
|
25.0%
4/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
4/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
50.0%
2/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Gastrointestinal disorders
Nausea
|
43.8%
7/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
43.8%
7/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
50.0%
2/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
50.0%
1/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
33.3%
1/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Gastrointestinal disorders
Vomiting
|
18.8%
3/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
18.8%
3/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
50.0%
2/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Nervous system disorders
Spasticity
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
General disorders
Chills
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
General disorders
Edema face
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
33.3%
1/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
General disorders
Edema limbs
|
31.2%
5/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
31.2%
5/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
33.3%
1/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
General disorders
Edema trunk
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
General disorders
Fatigue
|
50.0%
8/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
50.0%
8/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
33.3%
1/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
50.0%
2/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
100.0%
2/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
50.0%
2/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
General disorders
Fever
|
12.5%
2/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
12.5%
2/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
33.3%
1/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
General disorders
Flu like symptoms
|
12.5%
2/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
12.5%
2/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
General disorders
Infusion related reaction
|
12.5%
2/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
12.5%
2/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
General disorders
Localized edema
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
General disorders
Malaise
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
General disorders
Pain
|
31.2%
5/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
31.2%
5/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
33.3%
1/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
50.0%
2/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
50.0%
1/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
50.0%
2/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
12.5%
2/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
12.5%
2/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Immune system disorders
Allergic reaction
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Infections and infestations
Lung infection
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
33.3%
1/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Infections and infestations
Papulopustular rash
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Infections and infestations
Sinusitis
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Infections and infestations
Skin infection
|
18.8%
3/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
18.8%
3/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Infections and infestations
Upper respiratory infection
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Infections and infestations
Vaginal infection
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Injury, poisoning and procedural complications
Bruising
|
12.5%
2/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
12.5%
2/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Injury, poisoning and procedural complications
Burn
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Injury, poisoning and procedural complications
Fall
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Investigations
Alanine aminotransferase increased
|
31.2%
5/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
31.2%
5/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
66.7%
2/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Investigations
Alkaline phosphatase increased
|
12.5%
2/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
12.5%
2/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
66.7%
2/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Investigations
Aspartate aminotransferase increased
|
31.2%
5/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
31.2%
5/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
33.3%
1/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
50.0%
1/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Investigations
Blood bilirubin increased
|
18.8%
3/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
18.8%
3/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Investigations
Cholesterol high
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Investigations
Creatinine increased
|
31.2%
5/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
31.2%
5/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
33.3%
1/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Investigations
Lipase increased
|
31.2%
5/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
31.2%
5/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
33.3%
1/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
50.0%
2/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Investigations
Lymphocyte count increased
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Investigations
Platelet count decreased
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Investigations
Serum amylase increased
|
25.0%
4/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
4/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Investigations
Weight loss
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
66.7%
2/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
50.0%
1/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Investigations
Investigations - Other, specify
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
50.0%
2/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Metabolism and nutrition disorders
Anorexia
|
31.2%
5/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
31.2%
5/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
33.3%
1/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
33.3%
1/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
50.0%
1/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
33.3%
1/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
12.5%
2/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
12.5%
2/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
12.5%
2/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
12.5%
2/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
33.3%
1/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
50.0%
1/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
18.8%
3/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
18.8%
3/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
2/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
12.5%
2/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
33.3%
1/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
50.0%
2/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
18.8%
3/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
18.8%
3/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
33.3%
1/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
12.5%
2/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
12.5%
2/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
33.3%
1/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
50.0%
1/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Nervous system disorders
Dizziness
|
18.8%
3/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
18.8%
3/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Nervous system disorders
Facial muscle weakness
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Nervous system disorders
Headache
|
31.2%
5/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
31.2%
5/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
75.0%
3/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
50.0%
1/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Nervous system disorders
Lethargy
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Nervous system disorders
Movements involuntary
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
33.3%
1/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Nervous system disorders
Syncope
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Psychiatric disorders
Anxiety
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Psychiatric disorders
Insomnia
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
33.3%
1/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Renal and urinary disorders
Urinary frequency
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
33.3%
1/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
37.5%
6/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
37.5%
6/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
33.3%
1/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
100.0%
2/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
62.5%
10/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
62.5%
10/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
33.3%
1/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
100.0%
2/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.5%
2/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
12.5%
2/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
33.3%
1/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
33.3%
1/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
50.0%
1/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
33.3%
1/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
50.0%
2/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
50.0%
2/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.5%
2/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
12.5%
2/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
37.5%
6/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
37.5%
6/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
75.0%
3/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
50.0%
2/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
25.0%
4/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
4/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
100.0%
4/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
50.0%
2/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Vascular disorders
Flushing
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Vascular disorders
Hypertension
|
25.0%
4/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
4/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Vascular disorders
Hypotension
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
6.2%
1/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
|
Vascular disorders
Lymphedema
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/16 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/3 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/2 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
0.00%
0/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
|
25.0%
1/4 • Adverse events were assessed every two weeks while participants were on treatment and within 30 days after the last dose. Participants at DTC cohort received a median treatment duration of 163.0 days (range 21.0-734.0), for MTC cohort 58.0 days (range 30.0 - 252.0), and for ATC cohort 135.5 days (range 10.0 - 735.0). For death, median follow-up for DTC cohort was 24.0 months (range 1.84 - 24.7), for MTC cohort 24.0 months (range 23.0-24.2), and for ATC cohort 22.2 months (range 0.46 - 26.1).
SAE defined as any expected or unexpected adverse event, related or unrelated to the therapy being studied, occurring at any agent dose, any phase of product, or procedure testing, that results in any of the following outcomes:death, a life-threatening adverse event requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity new cancer, congenital anomaly or birth defect. All others were OAEs.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place