Trial Outcomes & Findings for High-Risk Skin Cancers With Atezolizumab Plus NT-I7 (NCT NCT03901573)
NCT ID: NCT03901573
Last Updated: 2025-10-22
Results Overview
1. Incidence, nature, and severity of adverse events graded according to NCI CTCAE 5.0 2. Incidence and nature of dose-limiting toxicities (DLTs) Note: ORR (Defined as the percentage of patients who have at least one confirmed partial response (PR) or complete response (CR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1). ORR is included in Phase 2a Primary Outcome Measure.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
31 participants
Primary outcome timeframe
1. On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment) 2.First 21 days (C1/D1 through Day 21)
Results posted on
2025-10-22
Participant Flow
Participant milestones
| Measure |
Phase 1b-Dose Level 1
NT-I7 120 µg/kg IM Q3W
\+ atezolizumab 1200 mg IV Q3W
|
Phase 1b-Dose Level 2
NT-I7 360 µg/kg IM Q3W
\+ atezolizumab 1200 mg IV Q3W
|
Phase 1b-Dose Level 3
NT-I7 840 µg/kg IM Q3W
\+ atezolizumab 1200 mg IV Q6W
|
Phase 1b-Dose Level 4
NT-I7 1200 µg/kg IM Q6W
\+ atezolizumab 1200 mg IV Q6W
|
Phase 2-
NT-I7 1200 µg/kg IM Q6W
\+ atezolizumab 1200 mg IV Q6W
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
7
|
3
|
15
|
|
Overall Study
COMPLETED
|
2
|
2
|
4
|
3
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
3
|
0
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
High-Risk Skin Cancers With Atezolizumab Plus NT-I7
Baseline characteristics by cohort
| Measure |
Phase 1b
n=16 Participants
Baseline characteristics are summarized by dose level (Phase 1b: 120, 360, 840, 1200 μg/kg; Phase 2a: 1200 μg/kg) rather than by Arm because pooling was pre-specified in the Statistical Analysis Plan (Section 4.2.1) and protocol. Efficacy analyses also pool Phase 1b doses (120-840 μg/kg) and Phase 2a 1200 μg/kg dose. This approach reflects study design and planned analyses.
|
Phase 2a
n=15 Participants
Baseline characteristics are summarized by dose level (Phase 1b: 120, 360, 840, 1200 μg/kg; Phase 2a: 1200 μg/kg) rather than by Arm because pooling was pre-specified in the Statistical Analysis Plan (Section 4.2.1) and protocol. Efficacy analyses also pool Phase 1b doses (120-840 μg/kg) and Phase 2a 1200 μg/kg dose. This approach reflects study design and planned analyses.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Continuous
|
65.4 years
n=5 Participants
|
65.7 years
n=7 Participants
|
65.58 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
15 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Weight
|
81.42 kg
n=5 Participants
|
78.00 kg
n=7 Participants
|
79.71 kg
n=5 Participants
|
PRIMARY outcome
Timeframe: 1. On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment) 2.First 21 days (C1/D1 through Day 21)Population: Safety: All patients who receive at least 1 dose of the investigational regimen ; DLT: All patients who receive at least 1 dose of the investigational regimen and complete the full 3-week DLT window or who do not complete the full 3-week DLT window due to the occurrence of a DLT.; Analyses of adverse events will be performed for those events that are considered treatment emergent.(Subjects with one or more AEs within a level of MedDRA are counted only once in that level)
1. Incidence, nature, and severity of adverse events graded according to NCI CTCAE 5.0 2. Incidence and nature of dose-limiting toxicities (DLTs) Note: ORR (Defined as the percentage of patients who have at least one confirmed partial response (PR) or complete response (CR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1). ORR is included in Phase 2a Primary Outcome Measure.
Outcome measures
| Measure |
Phase 1b-Dose Level 1
n=3 Participants
NT-I7 120 µg/kg IM Q3W
\+ atezolizumab 1200 mg IV Q3W
|
Phase 1b-Dose Level 2
n=3 Participants
NT-I7 360 µg/kg IM Q3W
\+ atezolizumab 1200 mg IV Q3W
|
Phase 1b-Dose Level 3
n=7 Participants
NT-I7 840 µg/kg IM Q3W
\+ atezolizumab 1200 mg IV Q6W
|
Phase 1b-Dose Level 4
n=3 Participants
NT-I7 1200 µg/kg IM Q6W
\+ atezolizumab 1200 mg IV Q6W
|
Phase 2-
n=15 Participants
NT-I7 1200 µg/kg IM Q6W
\+ atezolizumab 1200 mg IV Q6W
|
|---|---|---|---|---|---|
|
Phase 1b: To Evaluate the Safety and Tolerability of NT-I7 in Combination With Atezolizumab, Including Estimation of the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose
Incidence of Treatment-Related TEAE
|
3 Participants
|
3 Participants
|
7 Participants
|
3 Participants
|
14 Participants
|
|
Phase 1b: To Evaluate the Safety and Tolerability of NT-I7 in Combination With Atezolizumab, Including Estimation of the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose
Patient Incidence of Serious Treatment-Emergent Adverse Events
|
1 Participants
|
0 Participants
|
5 Participants
|
1 Participants
|
9 Participants
|
|
Phase 1b: To Evaluate the Safety and Tolerability of NT-I7 in Combination With Atezolizumab, Including Estimation of the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose
Patient Incidence of Serious Treatment-Related Adverse Events
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
4 Participants
|
|
Phase 1b: To Evaluate the Safety and Tolerability of NT-I7 in Combination With Atezolizumab, Including Estimation of the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose
Patient Incidence of Adverse Events of Special Interest
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
9 Participants
|
|
Phase 1b: To Evaluate the Safety and Tolerability of NT-I7 in Combination With Atezolizumab, Including Estimation of the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose
Experienced a DLT
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: C1D1 until the start of a new anticancer treatment, disease progression, pregnancy, death, withdrawal of consent or end of study, whichever occurs first, up to 1 yearPopulation: The Arm/Group has been categorized based on the dosing regimen of NT-I7 per study design: Phase 1b, DL1-3 every 3 weeks (Q3W); Phase 1b DL4 and Phase 2a, Q6W.treatment and have at least one evaluable post baseline tumor assessment.
Pooling of dose levels for this Outcome Measure was pre-specified in the Statistical Analysis Plan (SAP Section 4.2.1) and the study protocol. Phase 1b dose-escalation results are summarized by dose level (120, 360, 840, 1200 µg/kg), and Phase 2a results under 1200 µg/kg. Efficacy analyses pool Phase 1b doses (120-840 µg/kg) and the Phase 2a 1200 µg/kg dose to reflect the predefined analysis strategy and study objectives. This approach was chosen due to small sample sizes and early study termination, as documented in the Clinical Study Report (CSR).
Outcome measures
| Measure |
Phase 1b-Dose Level 1
n=12 Participants
NT-I7 120 µg/kg IM Q3W
\+ atezolizumab 1200 mg IV Q3W
|
Phase 1b-Dose Level 2
n=15 Participants
NT-I7 360 µg/kg IM Q3W
\+ atezolizumab 1200 mg IV Q3W
|
Phase 1b-Dose Level 3
NT-I7 840 µg/kg IM Q3W
\+ atezolizumab 1200 mg IV Q6W
|
Phase 1b-Dose Level 4
NT-I7 1200 µg/kg IM Q6W
\+ atezolizumab 1200 mg IV Q6W
|
Phase 2-
NT-I7 1200 µg/kg IM Q6W
\+ atezolizumab 1200 mg IV Q6W
|
|---|---|---|---|---|---|
|
Phase 2a: To Evaluate the Objective Response Rate (ORR) According to RECIST 1.1 and iRECIST, as Determined by the Investigator
Complete response
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Phase 2a: To Evaluate the Objective Response Rate (ORR) According to RECIST 1.1 and iRECIST, as Determined by the Investigator
Partial response
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Phase 2a: To Evaluate the Objective Response Rate (ORR) According to RECIST 1.1 and iRECIST, as Determined by the Investigator
Stable disease
|
9 Participants
|
6 Participants
|
—
|
—
|
—
|
|
Phase 2a: To Evaluate the Objective Response Rate (ORR) According to RECIST 1.1 and iRECIST, as Determined by the Investigator
Progressive disease
|
3 Participants
|
7 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: C1D1 through end of 90-day follow-upPopulation: All patients who receive at least 1 dose of the investigational regimen.
The ADA status will be defined using the baseline and postbaseline results. Anti-drug antibody negative is defined as negative results at all time points. Anti-drug antibody positive is defined as a positive result at any time point, including baseline.
Outcome measures
| Measure |
Phase 1b-Dose Level 1
n=3 Participants
NT-I7 120 µg/kg IM Q3W
\+ atezolizumab 1200 mg IV Q3W
|
Phase 1b-Dose Level 2
n=3 Participants
NT-I7 360 µg/kg IM Q3W
\+ atezolizumab 1200 mg IV Q3W
|
Phase 1b-Dose Level 3
n=7 Participants
NT-I7 840 µg/kg IM Q3W
\+ atezolizumab 1200 mg IV Q6W
|
Phase 1b-Dose Level 4
n=3 Participants
NT-I7 1200 µg/kg IM Q6W
\+ atezolizumab 1200 mg IV Q6W
|
Phase 2-
n=15 Participants
NT-I7 1200 µg/kg IM Q6W
\+ atezolizumab 1200 mg IV Q6W
|
|---|---|---|---|---|---|
|
To Evaluate Immunogenicity of NT-I7 in Combination With Atezolizumab
Baseline · Subjects that are ADA Positive
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
To Evaluate Immunogenicity of NT-I7 in Combination With Atezolizumab
Baseline · Subjects that are ADA Negative
|
3 Participants
|
3 Participants
|
7 Participants
|
3 Participants
|
12 Participants
|
|
To Evaluate Immunogenicity of NT-I7 in Combination With Atezolizumab
Baseline · n (Missing)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
To Evaluate Immunogenicity of NT-I7 in Combination With Atezolizumab
C2D1 · Subjects that are ADA Negative
|
0 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
|
To Evaluate Immunogenicity of NT-I7 in Combination With Atezolizumab
C2D1 · Subjects that are ADA Positive
|
3 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
11 Participants
|
|
To Evaluate Immunogenicity of NT-I7 in Combination With Atezolizumab
C2D1 · n (Missing)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
To Evaluate Immunogenicity of NT-I7 in Combination With Atezolizumab
End of Treatment · Subjects that are ADA Negative
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
To Evaluate Immunogenicity of NT-I7 in Combination With Atezolizumab
End of Treatment · n (Missing)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
6 Participants
|
|
To Evaluate Immunogenicity of NT-I7 in Combination With Atezolizumab
End of Treatment · Subjects that are ADA Positive
|
3 Participants
|
2 Participants
|
7 Participants
|
3 Participants
|
9 Participants
|
|
To Evaluate Immunogenicity of NT-I7 in Combination With Atezolizumab
90-Day Follow up · Subjects that are ADA Positive
|
2 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
|
To Evaluate Immunogenicity of NT-I7 in Combination With Atezolizumab
90-Day Follow up · n (Missing)
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
11 Participants
|
|
To Evaluate Immunogenicity of NT-I7 in Combination With Atezolizumab
90-Day Follow up · Subjects that are ADA Negative
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: C1D1 until the start of a new anticancer treatment, disease progression, pregnancy, death, withdrawal of consent or end of study, whichever occurs first, up to 1 yearPopulation: Defined as the time from the first occurrence of stable disease or better (PR or CR or SD) to the time of the first documented disease progression or death from any cause, whichever occurs first per RECIST v1.1. The Arm/Group has been categorized based on the dosing regimen of NT-I7 per study design: Phase 1b, DL1-3 every 3 weeks (Q3W); Phase 1b DL4 and Phase 2a, Q6W.
Pooling of dose levels for this Outcome Measure was also pre-specified in the SAP and study protocol to maintain consistency across efficacy endpoints. For this Outcome Measure (e.g., Disease Control Rate), pooled groups were defined as Phase 1b (120-840 µg/kg) and Phase 2a (1200 µg/kg). This approach aligns with the predefined analyses and study objectives and prevents misleading subgroup estimates given the limited enrollment and early study termination.
Outcome measures
| Measure |
Phase 1b-Dose Level 1
n=12 Participants
NT-I7 120 µg/kg IM Q3W
\+ atezolizumab 1200 mg IV Q3W
|
Phase 1b-Dose Level 2
n=15 Participants
NT-I7 360 µg/kg IM Q3W
\+ atezolizumab 1200 mg IV Q3W
|
Phase 1b-Dose Level 3
NT-I7 840 µg/kg IM Q3W
\+ atezolizumab 1200 mg IV Q6W
|
Phase 1b-Dose Level 4
NT-I7 1200 µg/kg IM Q6W
\+ atezolizumab 1200 mg IV Q6W
|
Phase 2-
NT-I7 1200 µg/kg IM Q6W
\+ atezolizumab 1200 mg IV Q6W
|
|---|---|---|---|---|---|
|
To Make a Preliminary Assessment of the Anti-tumor Activity of NT-I7 in Combination With Atezolizumab
Duration of stable disease
|
2.2 Months
Interval 1.41 to 12.25
|
2.0 Months
Interval 1.45 to 2.27
|
—
|
—
|
—
|
|
To Make a Preliminary Assessment of the Anti-tumor Activity of NT-I7 in Combination With Atezolizumab
Progression -Free Survival, RECIST 1.1
|
4.2 Months
Interval 2.07 to 6.93
|
3.5 Months
Interval 1.87 to 4.24
|
—
|
—
|
—
|
|
To Make a Preliminary Assessment of the Anti-tumor Activity of NT-I7 in Combination With Atezolizumab
Overall Survival
|
11.1 Months
Interval 3.81 to 22.24
|
NA Months
Interval 5.06 to
The cohort didn't reach 50% survival within the observation period
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: C1D1 until the start of a new anticancer treatment, disease progression, pregnancy, death, withdrawal of consent or end of study, whichever occurs first, up to 1 yearPopulation: All patients who received at least one cycle of study treatment and have at least one evaluable post baseline tumor assessment. The Arm/Group has been categorized based on the dosing regimen of NT-I7 per study design: Phase 1b, DL1-3 every 3 weeks (Q3W); Phase 1b DL4 and Phase 2a, Q6W.
For Outcome Measure 4 and 5, pooling was also pre-specified in SAP Section 4.8 and CSR Section 11.4. Kaplan-Meier analyses were conducted on pooled groups for interpretability and statistical validity. Separate reporting by Arm was not feasible due to small sample sizes and early termination.
Outcome measures
| Measure |
Phase 1b-Dose Level 1
n=12 Participants
NT-I7 120 µg/kg IM Q3W
\+ atezolizumab 1200 mg IV Q3W
|
Phase 1b-Dose Level 2
n=15 Participants
NT-I7 360 µg/kg IM Q3W
\+ atezolizumab 1200 mg IV Q3W
|
Phase 1b-Dose Level 3
NT-I7 840 µg/kg IM Q3W
\+ atezolizumab 1200 mg IV Q6W
|
Phase 1b-Dose Level 4
NT-I7 1200 µg/kg IM Q6W
\+ atezolizumab 1200 mg IV Q6W
|
Phase 2-
NT-I7 1200 µg/kg IM Q6W
\+ atezolizumab 1200 mg IV Q6W
|
|---|---|---|---|---|---|
|
To Make a Preliminary Assessment of the Anti-tumor Activity of NT-I7 in Combination With Atezolizumab (DCR)
|
75.0 percentage of participants
|
53.3 percentage of participants
|
—
|
—
|
—
|
Adverse Events
Phase 1b-Dose Level 1
Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths
Phase 1b-Dose Level 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 3 deaths
Phase 1b-Dose Level 3
Serious events: 5 serious events
Other events: 7 other events
Deaths: 5 deaths
Phase 1b-Dose Level 4
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase 2-
Serious events: 9 serious events
Other events: 14 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Phase 1b-Dose Level 1
n=3 participants at risk
NT-I7 120 µg/kg IM Q3W
\+ atezolizumab 1200 mg IV Q3W
|
Phase 1b-Dose Level 2
n=3 participants at risk
NT-I7 360 µg/kg IM Q3W
\+ atezolizumab 1200 mg IV Q3W
|
Phase 1b-Dose Level 3
n=7 participants at risk
NT-I7 840 µg/kg IM Q3W
\+ atezolizumab 1200 mg IV Q6W
|
Phase 1b-Dose Level 4
n=3 participants at risk
NT-I7 1200 µg/kg IM Q6W
\+ atezolizumab 1200 mg IV Q6W
|
Phase 2-
n=15 participants at risk
NT-I7 1200 µg/kg IM Q6W
\+ atezolizumab 1200 mg IV Q6W
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
General disorders
Fatigue
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
General disorders
Injection site reaction
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
General disorders
Peripheral swelling
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Infections and infestations
Cystitis
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Infections and infestations
Endocarditis
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
28.6%
2/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
13.3%
2/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Social circumstances
Loss of personal independence in daily activities
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
Other adverse events
| Measure |
Phase 1b-Dose Level 1
n=3 participants at risk
NT-I7 120 µg/kg IM Q3W
\+ atezolizumab 1200 mg IV Q3W
|
Phase 1b-Dose Level 2
n=3 participants at risk
NT-I7 360 µg/kg IM Q3W
\+ atezolizumab 1200 mg IV Q3W
|
Phase 1b-Dose Level 3
n=7 participants at risk
NT-I7 840 µg/kg IM Q3W
\+ atezolizumab 1200 mg IV Q6W
|
Phase 1b-Dose Level 4
n=3 participants at risk
NT-I7 1200 µg/kg IM Q6W
\+ atezolizumab 1200 mg IV Q6W
|
Phase 2-
n=15 participants at risk
NT-I7 1200 µg/kg IM Q6W
\+ atezolizumab 1200 mg IV Q6W
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Blood and lymphatic system disorders
Eosinophilia
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Blood and lymphatic system disorders
Leukocytosis
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Endocrine disorders
Hypothyroidism
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Endocrine disorders
Dry eye
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
13.3%
2/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
28.6%
2/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
20.0%
3/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Infections and infestations
Rash pustular
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
13.3%
2/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
100.0%
3/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
13.3%
2/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Investigations
Blood alkaline phosphatase
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
66.7%
2/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
13.3%
2/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Investigations
Blood creatinine increased
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Investigations
Blood lactate dehydrogenase
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
28.6%
2/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
13.3%
2/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Investigations
Brain natriuretic peptide increased
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
13.3%
2/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Investigations
Lipase increased
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
42.9%
3/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Investigations
Platelet count decreased
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Investigations
Weight increased
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
28.6%
2/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
66.7%
2/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
28.6%
2/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
26.7%
4/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
28.6%
2/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
20.0%
3/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
42.9%
3/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
42.9%
3/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
66.7%
2/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
13.3%
2/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
28.6%
2/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
42.9%
3/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
66.7%
2/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
20.0%
3/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Metabolism and nutrition disorders
Hypophosphatasemia
|
100.0%
3/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
28.6%
2/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
13.3%
2/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
13.3%
2/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Musculoskeletal and connective tissue disorders
Muscle swelling
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
13.3%
2/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Metabolism and nutrition disorders
Pain in extremity
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
13.3%
2/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
28.6%
2/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
13.3%
2/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Nervous system disorders
Dysgeusia
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
66.7%
2/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
66.7%
2/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
20.0%
3/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Renal and urinary disorders
Confusional state
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
13.3%
2/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
13.3%
2/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
28.6%
2/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
28.6%
2/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
26.7%
4/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
13.3%
2/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
66.7%
2/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
66.7%
2/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
42.9%
3/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
33.3%
5/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
20.0%
3/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Skin and subcutaneous tissue disorders
Skin discoloration
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
General disorders
Chest pain
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
General disorders
Chills
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
General disorders
Fatigue
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
66.7%
2/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
57.1%
4/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
66.7%
2/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
53.3%
8/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
General disorders
General physical health deterioration
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
26.7%
4/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
General disorders
Injection site dryness
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
General disorders
Injection site erythema
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
General disorders
Injection site induration
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
General disorders
Injection site pain
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
General disorders
Injection site pruritus
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
General disorders
Injection site reaction
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
42.9%
3/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
66.7%
2/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
46.7%
7/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
General disorders
Localized oedema
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
General disorders
Nodule
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
General disorders
Pain
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
General disorders
Peripheral swelling
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
General disorders
Pyrexia
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
33.3%
5/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
General disorders
Oedema peripheral
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
28.6%
2/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
66.7%
2/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Gastrointestinal disorders
Abdominal distension
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Gastrointestinal disorders
Dyspepsis
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
General disorders
Asthenia
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
General disorders
Cyst
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
General disorders
Gait disturbance
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
General disorders
Infusion site extravasation
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Infections and infestations
Cystitis
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Infections and infestations
Endocarditis
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Infections and infestations
Nasopharyngitis
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
28.6%
2/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Investigations
Hip fracture
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Investigations
Blood phosphorus increased
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Investigations
Enterobacter test positive
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Investigations
International normalised ratio increased
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Investigations
Investigation abnormal
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Investigations
Lymphocyte count
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Investigations
Neutrophil count increased
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Investigations
Procalcitonin increased
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Investigations
Respiratory rate increased
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Investigations
Weight decreased
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
13.3%
2/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Metabolism and nutrition disorders
Hypermagnesaemi
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
66.7%
2/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Musculoskeletal and connective tissue disorders
Limb mass
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Metabolism and nutrition disorders
Musculoskeletal pain
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Nervous system disorders
Amnesia
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
33.3%
1/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Skin and subcutaneous tissue disorders
Skin plaque
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Social circumstances
Loss of personal independence in daily activities
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
13.3%
2/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Investigations
Troponin T increased
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
14.3%
1/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/7 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
0.00%
0/3 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
6.7%
1/15 • On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment)
Incidence of Treatment-Related TEAE by MedDRA System Organ Class and Preferred Term (Safety Population)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place