Trial Outcomes & Findings for Tabelecleucel in Combination With Pembrolizumab in Subjects With Epstein-Barr Virus-associated Nasopharyngeal Carcinoma (EBV+ NPC) (NCT NCT03769467)
NCT ID: NCT03769467
Last Updated: 2024-11-14
Results Overview
The occurrence of any of the following toxicities during Treatment Cycle 1 will be considered a DLT, if assessed by the investigator to be possibly related or related to investigational product administration (either tabelecleucel and/or pembrolizumab): Grade (G) 4 nonhematologic toxicity; G4 hematologic toxicity lasting \>=7 days, except thrombocytopenia; any nonhematologic AE \>=G3, except G3 fatigue lasting =\<3 days; G3 diarrhea, nausea, or vomiting; G3 rash; Any G3/4 non-hematologic laboratory value if clinically significant medical intervention is required to treat the participant, abnormality leads to hospitalization, abnormality persists for \> 1 week, abnormality results in a Drug-induced Liver Injury (DILI); G3/4 febrile neutropenia; \> 2 weeks delay in initiating Cycle 2; discontinue treatment during Cycle 1; missing \> 25% of study drugs doses as a result of investigational product-related AEs during the first cycle;G5 toxicity.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
12 participants
Primary outcome timeframe
From Day 1 through Day 21 of Cycle 1
Results posted on
2024-11-14
Participant Flow
A total of 12 participants were enrolled in phase 1b (cohort 1). No participants were enrolled in phase 2 (cohort 2) due to early study termination.
Participant milestones
| Measure |
Cohort 1B: Checkpoint Inhibitor Naïve
Checkpoint inhibitor naive subjects during the treatment phase received intravenous (IV) infusion of pembrolizumab at 200 mg for adults (≥ 18 years of age) or 2 mg/kg for adolescents (12 to \< 18 years of age) prior to the administration of tabelecleucel on Day 1; and IV infusion of tabelecleucel (tab-cel) at 2 x 10\^6 T-cells/kg on Days 1, 8, and 15 of each 21-day treatment/consolidation cycles (at least 2 cycles or up to 4 cycles). From the Maintenance Phase, subjects with stable disease or better will receive tabelecleucel on Day 1 and pembrolizumab on Day 1, Day 21, Day 42, and Day 63 of each 84- day maintenance cycle, which was continued until disease progression, unacceptable toxicity, or a total of 35 pembrolizumab infusions (including for treatment, consolidation, and maintenance) had been administered, whichever occurred first.
|
Cohort 1B: Checkpoint Inhibitor PD-1/PD-L1 Failure
Checkpoint inhibitor PD-1/PD-L1 failure subjects during the treatment phase received IV infusion of pembrolizumab at 200 mg for adults (≥ 18 years of age) or 2 mg/kg for adolescents (12 to \< 18 years of age) prior to the administration of tabelecleucel on Day 1; and IV infusion of tabelecleucel (tab-cel) at 2 x 10\^6 T-cells/kg on Days 1, 8, and 15 of each 21-day treatment/consolidation cycles (at least 2 cycles or up to 4 cycles). From the Maintenance Phase, subjects with stable disease or better will receive tabelecleucel on Day 1 and pembrolizumab on Day 1, Day 21, Day 42, and Day 63 of each 84-day maintenance cycle, which was continued until disease progression, unacceptable toxicity, or a total of 35 pembrolizumab infusions (including for treatment, consolidation, and maintenance) had been administered, whichever occurred first.
|
Cohort 2: Checkpoint Inhibitor Naïve
Checkpoint inhibitor naive subjects during the treatment phase received IV infusion of pembrolizumab at 200 mg for adults (≥ 18 years of age) or 2 mg/kg for adolescents (12 to \< 18 years of age) prior to the administration of tabelecleucel on Day 1; and IV infusion of tabelecleucel (tab-cel) at 2 x 10\^6 T-cells/kg on Days 1, 8, and 15 of each 21-day treatment/consolidation cycles (at least 2 cycles or up to 4 cycles). From the Maintenance Phase, subjects with stable disease or better will receive tabelecleucel on Day 1 and pembrolizumab on Day 1, Day 21, Day 42, and Day 63 of each 84- day maintenance cycle, which was continued until disease progression, unacceptable toxicity, or a total of 35 pembrolizumab infusions (including for treatment, consolidation, and maintenance) had been administered, whichever occurred first.
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1B: Checkpoint Inhibitor Naïve
Checkpoint inhibitor naive subjects during the treatment phase received intravenous (IV) infusion of pembrolizumab at 200 mg for adults (≥ 18 years of age) or 2 mg/kg for adolescents (12 to \< 18 years of age) prior to the administration of tabelecleucel on Day 1; and IV infusion of tabelecleucel (tab-cel) at 2 x 10\^6 T-cells/kg on Days 1, 8, and 15 of each 21-day treatment/consolidation cycles (at least 2 cycles or up to 4 cycles). From the Maintenance Phase, subjects with stable disease or better will receive tabelecleucel on Day 1 and pembrolizumab on Day 1, Day 21, Day 42, and Day 63 of each 84- day maintenance cycle, which was continued until disease progression, unacceptable toxicity, or a total of 35 pembrolizumab infusions (including for treatment, consolidation, and maintenance) had been administered, whichever occurred first.
|
Cohort 1B: Checkpoint Inhibitor PD-1/PD-L1 Failure
Checkpoint inhibitor PD-1/PD-L1 failure subjects during the treatment phase received IV infusion of pembrolizumab at 200 mg for adults (≥ 18 years of age) or 2 mg/kg for adolescents (12 to \< 18 years of age) prior to the administration of tabelecleucel on Day 1; and IV infusion of tabelecleucel (tab-cel) at 2 x 10\^6 T-cells/kg on Days 1, 8, and 15 of each 21-day treatment/consolidation cycles (at least 2 cycles or up to 4 cycles). From the Maintenance Phase, subjects with stable disease or better will receive tabelecleucel on Day 1 and pembrolizumab on Day 1, Day 21, Day 42, and Day 63 of each 84-day maintenance cycle, which was continued until disease progression, unacceptable toxicity, or a total of 35 pembrolizumab infusions (including for treatment, consolidation, and maintenance) had been administered, whichever occurred first.
|
Cohort 2: Checkpoint Inhibitor Naïve
Checkpoint inhibitor naive subjects during the treatment phase received IV infusion of pembrolizumab at 200 mg for adults (≥ 18 years of age) or 2 mg/kg for adolescents (12 to \< 18 years of age) prior to the administration of tabelecleucel on Day 1; and IV infusion of tabelecleucel (tab-cel) at 2 x 10\^6 T-cells/kg on Days 1, 8, and 15 of each 21-day treatment/consolidation cycles (at least 2 cycles or up to 4 cycles). From the Maintenance Phase, subjects with stable disease or better will receive tabelecleucel on Day 1 and pembrolizumab on Day 1, Day 21, Day 42, and Day 63 of each 84- day maintenance cycle, which was continued until disease progression, unacceptable toxicity, or a total of 35 pembrolizumab infusions (including for treatment, consolidation, and maintenance) had been administered, whichever occurred first.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
|
Overall Study
Death
|
3
|
3
|
0
|
|
Overall Study
Study Terminated By Sponsor
|
2
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
Tabelecleucel in Combination With Pembrolizumab in Subjects With Epstein-Barr Virus-associated Nasopharyngeal Carcinoma (EBV+ NPC)
Baseline characteristics by cohort
| Measure |
Cohort 1B: Checkpoint Inhibitor Naïve
n=6 Participants
Checkpoint inhibitor naive subjects during the treatment phase received intravenous (IV) infusion of pembrolizumab at 200 mg for adults (≥ 18 years of age) or 2 mg/kg for adolescents (12 to \< 18 years of age) prior to the administration of tabelecleucel on Day 1; and IV infusion of tabelecleucel (tab-cel) at 2 x 10\^6 T-cells/kg on Days 1, 8, and 15 of each 21-day treatment/consolidation cycles (at least 2 cycles or up to 4 cycles). From the Maintenance Phase, subjects with stable disease or better will receive tabelecleucel on Day 1 and pembrolizumab on Day 1, Day 21, Day 42, and Day 63 of each 84- day maintenance cycle, which was continued until disease progression, unacceptable toxicity, or a total of 35 pembrolizumab infusions (including for treatment, consolidation, and maintenance) had been administered, whichever occurred first.
|
Cohort 1B: Checkpoint Inhibitor PD-1/PD-L1 Failure
n=6 Participants
Checkpoint inhibitor PD-1/PD-L1 failure subjects during the treatment phase received IV infusion of pembrolizumab at 200 mg for adults (≥ 18 years of age) or 2 mg/kg for adolescents (12 to \< 18 years of age) prior to the administration of tabelecleucel on Day 1; and IV infusion of tabelecleucel (tab-cel) at 2 x 10\^6 T-cells/kg on Days 1, 8, and 15 of each 21-day treatment/consolidation cycles (at least 2 cycles or up to 4 cycles). From the Maintenance Phase, subjects with stable disease or better will receive tabelecleucel on Day 1 and pembrolizumab on Day 1, Day 21, Day 42, and Day 63 of each 84-day maintenance cycle, which was continued until disease progression, unacceptable toxicity, or a total of 35 pembrolizumab infusions (including for treatment, consolidation, and maintenance) had been administered, whichever occurred first.
|
Cohort 2: Checkpoint Inhibitor Naïve
Checkpoint inhibitor naive subjects during the treatment phase received IV infusion of pembrolizumab at 200 mg for adults (≥ 18 years of age) or 2 mg/kg for adolescents (12 to \< 18 years of age) prior to the administration of tabelecleucel on Day 1; and IV infusion of tabelecleucel (tab-cel) at 2 x 10\^6 T-cells/kg on Days 1, 8, and 15 of each 21-day treatment/consolidation cycles (at least 2 cycles or up to 4 cycles). From the Maintenance Phase, subjects with stable disease or better will receive tabelecleucel on Day 1 and pembrolizumab on Day 1, Day 21, Day 42, and Day 63 of each 84- day maintenance cycle, which was continued until disease progression, unacceptable toxicity, or a total of 35 pembrolizumab infusions (including for treatment, consolidation, and maintenance) had been administered, whichever occurred first.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
49.0 Years
STANDARD_DEVIATION 16.97 • n=5 Participants
|
53.0 Years
STANDARD_DEVIATION 3.16 • n=7 Participants
|
—
|
51.0 Years
STANDARD_DEVIATION 11.82 • n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From Day 1 through Day 21 of Cycle 1Population: Full analysis set included all participants who received at least one dose of investigational products (tabelecleucel or pembrolizumab) and were observed during the first 21 days of the first cycle.
The occurrence of any of the following toxicities during Treatment Cycle 1 will be considered a DLT, if assessed by the investigator to be possibly related or related to investigational product administration (either tabelecleucel and/or pembrolizumab): Grade (G) 4 nonhematologic toxicity; G4 hematologic toxicity lasting \>=7 days, except thrombocytopenia; any nonhematologic AE \>=G3, except G3 fatigue lasting =\<3 days; G3 diarrhea, nausea, or vomiting; G3 rash; Any G3/4 non-hematologic laboratory value if clinically significant medical intervention is required to treat the participant, abnormality leads to hospitalization, abnormality persists for \> 1 week, abnormality results in a Drug-induced Liver Injury (DILI); G3/4 febrile neutropenia; \> 2 weeks delay in initiating Cycle 2; discontinue treatment during Cycle 1; missing \> 25% of study drugs doses as a result of investigational product-related AEs during the first cycle;G5 toxicity.
Outcome measures
| Measure |
Cohort 1B: Checkpoint Inhibitor Naïve
n=6 Participants
Checkpoint inhibitor naive subjects during the treatment phase received IV infusion of pembrolizumab at 200 mg for adults (≥ 18 years of age) or 2 mg/kg for adolescents (12 to \< 18 years of age) prior to the administration of tabelecleucel on Day 1; and IV infusion of tabelecleucel (tab-cel) at 2 x 10\^6 T-cells/kg on Days 1, 8, and 15 of each 21-day treatment/consolidation cycles (at least 2 cycles or up to 4 cycles). From the Maintenance Phase, subjects with stable disease or better will receive tabelecleucel on Day 1 and pembrolizumab on Day 1, Day 21, Day 42, and Day 63 of each 84- day maintenance cycle, which was continued until disease progression, unacceptable toxicity, or a total of 35 pembrolizumab infusions (including for treatment, consolidation, and maintenance) had been administered, whichever occurred first.
|
Cohort 1B: Checkpoint Inhibitor PD-1/PD-L1 Failure
n=6 Participants
Checkpoint inhibitor PD-1/PD-L1 failure subjects during the treatment phase received IV infusion of pembrolizumab at 200 mg for adults (≥ 18 years of age) or 2 mg/kg for adolescents (12 to \< 18 years of age) prior to the administration of tabelecleucel on Day 1; and IV infusion of tabelecleucel (tab-cel) at 2 x 10\^6 T-cells/kg on Days 1, 8, and 15 of each 21-day treatment/consolidation cycles (at least 2 cycles or up to 4 cycles). From the Maintenance Phase, subjects with stable disease or better will receive tabelecleucel on Day 1 and pembrolizumab on Day 1, Day 21, Day 42, and Day 63 of each 84-day maintenance cycle, which was continued until disease progression, unacceptable toxicity, or a total of 35 pembrolizumab infusions (including for treatment, consolidation, and maintenance) had been administered, whichever occurred first.
|
|---|---|---|
|
Cohort 1B: Number of Participants With Dose-Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Day 1 through Day 21 of Cycle 21Population: The study was terminated before the outcome measure data were collected, refer to the Limitations and Caveats section for additional information.
The MTD is defined as the highest dose level at which the subject incidence of a DLTs during the first 21-day cycle of investigational product dosing is \< 33%
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: From Day 1 through Day 21 of Cycle 1Population: Full analysis set included all participants who received at least one dose of investigational products (tabelecleucel or pembrolizumab) and were observed during the first 21 days of the first cycle.
The RP2D is no higher than the maximum tolerated dose (highest dose level at which the number of participants with a DLTs during the first 21-day cycle of investigational product dosing is \< 33%) and is based on optimal benefit-risk, as determined by the Safety Data Review Committee (SDRC).
Outcome measures
| Measure |
Cohort 1B: Checkpoint Inhibitor Naïve
n=12 Participants
Checkpoint inhibitor naive subjects during the treatment phase received IV infusion of pembrolizumab at 200 mg for adults (≥ 18 years of age) or 2 mg/kg for adolescents (12 to \< 18 years of age) prior to the administration of tabelecleucel on Day 1; and IV infusion of tabelecleucel (tab-cel) at 2 x 10\^6 T-cells/kg on Days 1, 8, and 15 of each 21-day treatment/consolidation cycles (at least 2 cycles or up to 4 cycles). From the Maintenance Phase, subjects with stable disease or better will receive tabelecleucel on Day 1 and pembrolizumab on Day 1, Day 21, Day 42, and Day 63 of each 84- day maintenance cycle, which was continued until disease progression, unacceptable toxicity, or a total of 35 pembrolizumab infusions (including for treatment, consolidation, and maintenance) had been administered, whichever occurred first.
|
Cohort 1B: Checkpoint Inhibitor PD-1/PD-L1 Failure
Checkpoint inhibitor PD-1/PD-L1 failure subjects during the treatment phase received IV infusion of pembrolizumab at 200 mg for adults (≥ 18 years of age) or 2 mg/kg for adolescents (12 to \< 18 years of age) prior to the administration of tabelecleucel on Day 1; and IV infusion of tabelecleucel (tab-cel) at 2 x 10\^6 T-cells/kg on Days 1, 8, and 15 of each 21-day treatment/consolidation cycles (at least 2 cycles or up to 4 cycles). From the Maintenance Phase, subjects with stable disease or better will receive tabelecleucel on Day 1 and pembrolizumab on Day 1, Day 21, Day 42, and Day 63 of each 84-day maintenance cycle, which was continued until disease progression, unacceptable toxicity, or a total of 35 pembrolizumab infusions (including for treatment, consolidation, and maintenance) had been administered, whichever occurred first.
|
|---|---|---|
|
Cohort 1B: Recommended Phase 2 Dose (RP2D) of Tabelecleucel in Combination With Pembrolizumab
|
2000000 cells/kg
|
—
|
PRIMARY outcome
Timeframe: From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)Population: Full analysis set included all participants who received at least one dose of investigational products (tabelecleucel or pembrolizumab).
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as any AE occurring after initiation of the first dose of study treatment through 30 days after the last administration of study drugs or any pre-existing AE (ie, started prior to the first dose of study drugs) that worsened after the first dose through 30 days after the last administration of study drugs or any related AE on or after first dose.
Outcome measures
| Measure |
Cohort 1B: Checkpoint Inhibitor Naïve
n=6 Participants
Checkpoint inhibitor naive subjects during the treatment phase received IV infusion of pembrolizumab at 200 mg for adults (≥ 18 years of age) or 2 mg/kg for adolescents (12 to \< 18 years of age) prior to the administration of tabelecleucel on Day 1; and IV infusion of tabelecleucel (tab-cel) at 2 x 10\^6 T-cells/kg on Days 1, 8, and 15 of each 21-day treatment/consolidation cycles (at least 2 cycles or up to 4 cycles). From the Maintenance Phase, subjects with stable disease or better will receive tabelecleucel on Day 1 and pembrolizumab on Day 1, Day 21, Day 42, and Day 63 of each 84- day maintenance cycle, which was continued until disease progression, unacceptable toxicity, or a total of 35 pembrolizumab infusions (including for treatment, consolidation, and maintenance) had been administered, whichever occurred first.
|
Cohort 1B: Checkpoint Inhibitor PD-1/PD-L1 Failure
n=6 Participants
Checkpoint inhibitor PD-1/PD-L1 failure subjects during the treatment phase received IV infusion of pembrolizumab at 200 mg for adults (≥ 18 years of age) or 2 mg/kg for adolescents (12 to \< 18 years of age) prior to the administration of tabelecleucel on Day 1; and IV infusion of tabelecleucel (tab-cel) at 2 x 10\^6 T-cells/kg on Days 1, 8, and 15 of each 21-day treatment/consolidation cycles (at least 2 cycles or up to 4 cycles). From the Maintenance Phase, subjects with stable disease or better will receive tabelecleucel on Day 1 and pembrolizumab on Day 1, Day 21, Day 42, and Day 63 of each 84-day maintenance cycle, which was continued until disease progression, unacceptable toxicity, or a total of 35 pembrolizumab infusions (including for treatment, consolidation, and maintenance) had been administered, whichever occurred first.
|
|---|---|---|
|
Cohort 1B: Characterization of the Safety Profile: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Any TEAEs
|
6 Participants
|
6 Participants
|
|
Cohort 1B: Characterization of the Safety Profile: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
TEAEs (worst grade >=3)
|
1 Participants
|
4 Participants
|
|
Cohort 1B: Characterization of the Safety Profile: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
TEAEs fatal
|
0 Participants
|
0 Participants
|
|
Cohort 1B: Characterization of the Safety Profile: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
TEAEs leading to treatment interruption
|
0 Participants
|
0 Participants
|
|
Cohort 1B: Characterization of the Safety Profile: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
TEAEs leading to treatment discontinuation
|
4 Participants
|
4 Participants
|
|
Cohort 1B: Characterization of the Safety Profile: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Any TESAEs
|
1 Participants
|
1 Participants
|
|
Cohort 1B: Characterization of the Safety Profile: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
TEAEs related or possibly related to study treatment (worst grade >=3)
|
0 Participants
|
0 Participants
|
|
Cohort 1B: Characterization of the Safety Profile: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
TEAEs related or possibly related to study treatment; serious
|
0 Participants
|
1 Participants
|
|
Cohort 1B: Characterization of the Safety Profile: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
TEAEs related or possibly related to study treatment; fatal
|
0 Participants
|
0 Participants
|
|
Cohort 1B: Characterization of the Safety Profile: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
TEAEs related or possibly related to study treatment; leading to treatment interruption
|
0 Participants
|
0 Participants
|
|
Cohort 1B: Characterization of the Safety Profile: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
TEAEs related or possibly related to study treatment; leading to treatment discontinuation
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)Population: The study did not proceed to Cohort 2 (Phase 2) and data were not collected.
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as any AE occurring after initiation of the first dose of study treatment through 30 days after the last administration of study drugs or any pre-existing AE (ie, started prior to the first dose of study drugs) that worsened after the first dose through 30 days after the last administration of study drugs or any related AE on or after first dose
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)Population: The study did not proceed to Cohort 2 (Phase 2) and data were not collected.
For this study, radiographic tumor assessment was performed by computed tomography (CT) or magnetic resonance imaging (MRI) scan based on Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) and immune RECIST (iRECIST) criteria. Per RECIST v1.1, ORR is defined as percentage of participants with complete response (CR) (disappearance of all extranodal target lesions and all pathological lymph nodes must have decreased to \<10 mm in short axis) or partial response (PR) (at least a 30% decrease in sum of the longest diameters of target lesions taking as reference baseline sum diameters). Per iRECIST, immune complete response (iCR) is defined as resolution of all lesions and immune partial response (iPR) is defined as the target lesion sum of diameters (initial target lesions) not above initial progressive disease threshold, no significant growth in non-target lesion overall, and no new lesion or appearance of any new factor.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)Population: The study did not proceed to Cohort 2 (Phase 2) and data were not collected.
The CR rate is defined as percentage of participants with complete response. Per RECIST v1.1, CR is defined as disappearance of all extranodal target lesions and all pathological lymph nodes must have decreased \< 10 mm in short axis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)Population: The study did not proceed to Cohort 2 (Phase 2) and data were not collected.
Per RECIST v1.1, the DoR is defined as the time from the date of first documented confirmed response until date of documented progression or death in the absence of disease progression.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)Population: The study did not proceed to Cohort 2 (Phase 2) and data were not collected.
The PFS is defined as the time from the first dose of investigational product until the date of RECIST v1.1 defined progression or death due to any cause, whichever occurred first.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)Population: The study did not proceed to Cohort 2 (Phase 2) and data were not collected.
The OS is defined as the time from the first dose of investigational product to the date of death due to any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)Population: The study did not proceed to Cohort 2 (Phase 2) and data were not collected.
iRR is iCR + iPR. Per iRECIST, iCR is defined as resolution of all lesions and iPR is defined as the target lesion sum of diameters (initial target lesions) not above initial progressive disease threshold, no significant growth in non-target lesion overall, and no new lesion or appearance of any new factor.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)Population: The study did not proceed to Cohort 2 (Phase 2) and data were not collected.
DOiR is duration of iCR + iPR. Per iRECIST, iCR is defined as resolution of all lesions and iPR is defined as the target lesion sum of diameters (initial target lesions) not above initial progressive disease threshold, no significant growth in non-target lesion overall, and no new lesion or appearance of any new factor.
Outcome measures
Outcome data not reported
POST_HOC outcome
Timeframe: From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)Population: Full analysis set included all participants who received at least one dose of investigational products (tabelecleucel or pembrolizumab). Cohort 1B (Phase 1b) was not powered for efficacy.
For this study, radiographic tumor assessment was performed by CT or MRI scan based on RECIST v1.1 and iRECIST criteria. Per RECIST v1.1, ORR is defined as percentage of participants with CR (disappearance of all extranodal target lesions and all pathological lymph nodes must have decreased to \<10 mm in short axis) or PR (at least a 30% decrease in sum of the longest diameters of target lesions taking as reference baseline sum diameters). Per iRECIST, iCR is defined as resolution of all lesions and iPR is defined as the target lesion sum of diameters (initial target lesions) not above initial progressive disease threshold, no significant growth in non-target lesion overall, and no new lesion or appearance of any new factor. Refer also to the Limitations and Caveats section.
Outcome measures
| Measure |
Cohort 1B: Checkpoint Inhibitor Naïve
n=6 Participants
Checkpoint inhibitor naive subjects during the treatment phase received IV infusion of pembrolizumab at 200 mg for adults (≥ 18 years of age) or 2 mg/kg for adolescents (12 to \< 18 years of age) prior to the administration of tabelecleucel on Day 1; and IV infusion of tabelecleucel (tab-cel) at 2 x 10\^6 T-cells/kg on Days 1, 8, and 15 of each 21-day treatment/consolidation cycles (at least 2 cycles or up to 4 cycles). From the Maintenance Phase, subjects with stable disease or better will receive tabelecleucel on Day 1 and pembrolizumab on Day 1, Day 21, Day 42, and Day 63 of each 84- day maintenance cycle, which was continued until disease progression, unacceptable toxicity, or a total of 35 pembrolizumab infusions (including for treatment, consolidation, and maintenance) had been administered, whichever occurred first.
|
Cohort 1B: Checkpoint Inhibitor PD-1/PD-L1 Failure
n=6 Participants
Checkpoint inhibitor PD-1/PD-L1 failure subjects during the treatment phase received IV infusion of pembrolizumab at 200 mg for adults (≥ 18 years of age) or 2 mg/kg for adolescents (12 to \< 18 years of age) prior to the administration of tabelecleucel on Day 1; and IV infusion of tabelecleucel (tab-cel) at 2 x 10\^6 T-cells/kg on Days 1, 8, and 15 of each 21-day treatment/consolidation cycles (at least 2 cycles or up to 4 cycles). From the Maintenance Phase, subjects with stable disease or better will receive tabelecleucel on Day 1 and pembrolizumab on Day 1, Day 21, Day 42, and Day 63 of each 84-day maintenance cycle, which was continued until disease progression, unacceptable toxicity, or a total of 35 pembrolizumab infusions (including for treatment, consolidation, and maintenance) had been administered, whichever occurred first.
|
|---|---|---|
|
Cohort 1B: Objective Response Rate (ORR)
|
0 Percentage of Participants
Interval 0.0 to 45.9
|
0 Percentage of Participants
Interval 0.0 to 45.9
|
POST_HOC outcome
Timeframe: From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)Population: Full analysis set included all participants who received at least one dose of investigational products (tabelecleucel or pembrolizumab). Cohort 1B (phase 1b) was not powered for efficacy.
The CBR is defined as the proportion of subjects who achieved BOR of CR or PR or SD. CR and PR are defined in outcome measure of ORR. The SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. For this study, radiographic tumor assessment was performed by CT scan or MRI scan based on RECIST v1.1 and immune-based RECIST criteria. Refer also to the Limitations and Caveats section.
Outcome measures
| Measure |
Cohort 1B: Checkpoint Inhibitor Naïve
n=6 Participants
Checkpoint inhibitor naive subjects during the treatment phase received IV infusion of pembrolizumab at 200 mg for adults (≥ 18 years of age) or 2 mg/kg for adolescents (12 to \< 18 years of age) prior to the administration of tabelecleucel on Day 1; and IV infusion of tabelecleucel (tab-cel) at 2 x 10\^6 T-cells/kg on Days 1, 8, and 15 of each 21-day treatment/consolidation cycles (at least 2 cycles or up to 4 cycles). From the Maintenance Phase, subjects with stable disease or better will receive tabelecleucel on Day 1 and pembrolizumab on Day 1, Day 21, Day 42, and Day 63 of each 84- day maintenance cycle, which was continued until disease progression, unacceptable toxicity, or a total of 35 pembrolizumab infusions (including for treatment, consolidation, and maintenance) had been administered, whichever occurred first.
|
Cohort 1B: Checkpoint Inhibitor PD-1/PD-L1 Failure
n=6 Participants
Checkpoint inhibitor PD-1/PD-L1 failure subjects during the treatment phase received IV infusion of pembrolizumab at 200 mg for adults (≥ 18 years of age) or 2 mg/kg for adolescents (12 to \< 18 years of age) prior to the administration of tabelecleucel on Day 1; and IV infusion of tabelecleucel (tab-cel) at 2 x 10\^6 T-cells/kg on Days 1, 8, and 15 of each 21-day treatment/consolidation cycles (at least 2 cycles or up to 4 cycles). From the Maintenance Phase, subjects with stable disease or better will receive tabelecleucel on Day 1 and pembrolizumab on Day 1, Day 21, Day 42, and Day 63 of each 84-day maintenance cycle, which was continued until disease progression, unacceptable toxicity, or a total of 35 pembrolizumab infusions (including for treatment, consolidation, and maintenance) had been administered, whichever occurred first.
|
|---|---|---|
|
Cohort 1B: Clinical Benefit Rate (CBR)
|
66.7 Percentage of Participants
Interval 22.3 to 95.7
|
33.3 Percentage of Participants
Interval 4.3 to 77.7
|
Adverse Events
Cohort 1B: Checkpoint Inhibitor Naïve
Serious events: 1 serious events
Other events: 6 other events
Deaths: 3 deaths
Cohort 1B: Checkpoint Inhibitor PD-1/PD-L1 Failure
Serious events: 1 serious events
Other events: 6 other events
Deaths: 3 deaths
Cohort 2: Checkpoint Inhibitor Naïve
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1B: Checkpoint Inhibitor Naïve
n=6 participants at risk
Checkpoint inhibitor naive subjects during the treatment phase received intravenous (IV) infusion of pembrolizumab at 200 mg for adults (≥ 18 years of age) or 2 mg/kg for adolescents (12 to \< 18 years of age) prior to the administration of tabelecleucel on Day 1; and IV infusion of tabelecleucel (tab-cel) at 2 x 10\^6 T-cells/kg on Days 1, 8, and 15 of each 21-day treatment/consolidation cycles (at least 2 cycles or up to 4 cycles). From the Maintenance Phase, subjects with stable disease or better will receive tabelecleucel on Day 1 and pembrolizumab on Day 1, Day 21, Day 42, and Day 63 of each 84- day maintenance cycle, which was continued until disease progression, unacceptable toxicity, or a total of 35 pembrolizumab infusions (including for treatment, consolidation, and maintenance) had been administered, whichever occurred first.
|
Cohort 1B: Checkpoint Inhibitor PD-1/PD-L1 Failure
n=6 participants at risk
Checkpoint inhibitor PD-1/PD-L1 failure subjects during the treatment phase received IV infusion of pembrolizumab at 200 mg for adults (≥ 18 years of age) or 2 mg/kg for adolescents (12 to \< 18 years of age) prior to the administration of tabelecleucel on Day 1; and IV infusion of tabelecleucel (tab-cel) at 2 x 10\^6 T-cells/kg on Days 1, 8, and 15 of each 21-day treatment/consolidation cycles (at least 2 cycles or up to 4 cycles). From the Maintenance Phase, subjects with stable disease or better will receive tabelecleucel on Day 1 and pembrolizumab on Day 1, Day 21, Day 42, and Day 63 of each 84-day maintenance cycle, which was continued until disease progression, unacceptable toxicity, or a total of 35 pembrolizumab infusions (including for treatment, consolidation, and maintenance) had been administered, whichever occurred first.
|
Cohort 2: Checkpoint Inhibitor Naïve
Checkpoint inhibitor naive subjects during the treatment phase received IV infusion of pembrolizumab at 200 mg for adults (≥ 18 years of age) or 2 mg/kg for adolescents (12 to \< 18 years of age) prior to the administration of tabelecleucel on Day 1; and IV infusion of tabelecleucel (tab-cel) at 2 x 10\^6 T-cells/kg on Days 1, 8, and 15 of each 21-day treatment/consolidation cycles (at least 2 cycles or up to 4 cycles). From the Maintenance Phase, subjects with stable disease or better will receive tabelecleucel on Day 1 and pembrolizumab on Day 1, Day 21, Day 42, and Day 63 of each 84- day maintenance cycle, which was continued until disease progression, unacceptable toxicity, or a total of 35 pembrolizumab infusions (including for treatment, consolidation, and maintenance) had been administered, whichever occurred first.
|
|---|---|---|---|
|
General disorders
Chills
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Nervous system disorders
Brain oedema
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Nervous system disorders
Hemiparesis
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
Other adverse events
| Measure |
Cohort 1B: Checkpoint Inhibitor Naïve
n=6 participants at risk
Checkpoint inhibitor naive subjects during the treatment phase received intravenous (IV) infusion of pembrolizumab at 200 mg for adults (≥ 18 years of age) or 2 mg/kg for adolescents (12 to \< 18 years of age) prior to the administration of tabelecleucel on Day 1; and IV infusion of tabelecleucel (tab-cel) at 2 x 10\^6 T-cells/kg on Days 1, 8, and 15 of each 21-day treatment/consolidation cycles (at least 2 cycles or up to 4 cycles). From the Maintenance Phase, subjects with stable disease or better will receive tabelecleucel on Day 1 and pembrolizumab on Day 1, Day 21, Day 42, and Day 63 of each 84- day maintenance cycle, which was continued until disease progression, unacceptable toxicity, or a total of 35 pembrolizumab infusions (including for treatment, consolidation, and maintenance) had been administered, whichever occurred first.
|
Cohort 1B: Checkpoint Inhibitor PD-1/PD-L1 Failure
n=6 participants at risk
Checkpoint inhibitor PD-1/PD-L1 failure subjects during the treatment phase received IV infusion of pembrolizumab at 200 mg for adults (≥ 18 years of age) or 2 mg/kg for adolescents (12 to \< 18 years of age) prior to the administration of tabelecleucel on Day 1; and IV infusion of tabelecleucel (tab-cel) at 2 x 10\^6 T-cells/kg on Days 1, 8, and 15 of each 21-day treatment/consolidation cycles (at least 2 cycles or up to 4 cycles). From the Maintenance Phase, subjects with stable disease or better will receive tabelecleucel on Day 1 and pembrolizumab on Day 1, Day 21, Day 42, and Day 63 of each 84-day maintenance cycle, which was continued until disease progression, unacceptable toxicity, or a total of 35 pembrolizumab infusions (including for treatment, consolidation, and maintenance) had been administered, whichever occurred first.
|
Cohort 2: Checkpoint Inhibitor Naïve
Checkpoint inhibitor naive subjects during the treatment phase received IV infusion of pembrolizumab at 200 mg for adults (≥ 18 years of age) or 2 mg/kg for adolescents (12 to \< 18 years of age) prior to the administration of tabelecleucel on Day 1; and IV infusion of tabelecleucel (tab-cel) at 2 x 10\^6 T-cells/kg on Days 1, 8, and 15 of each 21-day treatment/consolidation cycles (at least 2 cycles or up to 4 cycles). From the Maintenance Phase, subjects with stable disease or better will receive tabelecleucel on Day 1 and pembrolizumab on Day 1, Day 21, Day 42, and Day 63 of each 84- day maintenance cycle, which was continued until disease progression, unacceptable toxicity, or a total of 35 pembrolizumab infusions (including for treatment, consolidation, and maintenance) had been administered, whichever occurred first.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Ear and labyrinth disorders
Ear pain
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Ear and labyrinth disorders
Otorrhoea
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Ear and labyrinth disorders
Tinnitus
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Endocrine disorders
Hyperthyroidism
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Endocrine disorders
Hypopituitarism
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Endocrine disorders
Hypothyroidism
|
33.3%
2/6 • Number of events 3 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Eye disorders
Blindness unilateral
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Eye disorders
Eye discharge
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Eye disorders
Eye irritation
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Eye disorders
Vision blurred
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Gastrointestinal disorders
Abdominal distension
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
16.7%
1/6 • Number of events 2 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
2/6 • Number of events 3 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Gastrointestinal disorders
Dry mouth
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
33.3%
2/6 • Number of events 3 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
33.3%
2/6 • Number of events 4 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
General disorders
Catheter site erythema
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
16.7%
1/6 • Number of events 2 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
General disorders
Chills
|
33.3%
2/6 • Number of events 3 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
General disorders
Disease progression
|
83.3%
5/6 • Number of events 5 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
50.0%
3/6 • Number of events 3 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
General disorders
Face oedema
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
16.7%
1/6 • Number of events 5 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
General disorders
Fatigue
|
33.3%
2/6 • Number of events 4 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
16.7%
1/6 • Number of events 3 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
General disorders
Nodule
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
33.3%
2/6 • Number of events 2 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
General disorders
Pyrexia
|
16.7%
1/6 • Number of events 2 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
33.3%
2/6 • Number of events 7 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Infections and infestations
Ear infection
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Infections and infestations
Otitis media
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Injury, poisoning and procedural complications
Fall
|
16.7%
1/6 • Number of events 2 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6 • Number of events 2 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Investigations
Blood alkaline phosphatase increased
|
16.7%
1/6 • Number of events 2 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Investigations
Platelet count decreased
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
16.7%
1/6 • Number of events 2 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Investigations
Serum ferritin increased
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Investigations
White blood cell count increased
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
16.7%
1/6 • Number of events 3 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
33.3%
2/6 • Number of events 3 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
33.3%
2/6 • Number of events 2 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
2/6 • Number of events 2 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
33.3%
2/6 • Number of events 2 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
16.7%
1/6 • Number of events 2 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
2/6 • Number of events 5 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
33.3%
2/6 • Number of events 2 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Nervous system disorders
Dysarthria
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Nervous system disorders
Facial paralysis
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Nervous system disorders
Facial motor skill dysfunction
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Nervous system disorders
Tremor
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Number of events 2 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
33.3%
2/6 • Number of events 2 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
2/6 • Number of events 2 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Skin and subcutaneous tissue disorders
Skin tightness
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
16.7%
1/6 • Number of events 1 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
—
0/0 • From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place