Trial Outcomes & Findings for A Phase 1/2 Study to Evaluate Axatilimab in Participants With Active cGVHD (NCT NCT03604692)
NCT ID: NCT03604692
Last Updated: 2025-09-15
Results Overview
A DLT was defined as the occurrence of any protocol-specified event within the first 28 days from the first dose of SNDX-6352 or administration of the third dose (Cycle 2 Day 1), whichever is later (from Cycle 1 Day 1 to Cycle 2 Day 1) and assessed by the Investigator as not being definitely attributable to underlying disease, disease progression, inter-current illness, concomitant medications or any other alternative cause.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
41 participants
Primary outcome timeframe
Day 1 through the first 28 days from the first dose of SNDX-6352 or administration of the third dose (Cycle 2 Day 1), whichever is later (from Cycle 1 Day 1 to Cycle 2 Day 1)
Results posted on
2025-09-15
Participant Flow
Participant milestones
| Measure |
Phase 1 Dose Escalation: SNDX-6352 0.15 mg/kg Q2W
Participants received an intravenous (IV) infusion of SNDX-6352 0.15 milligrams (mg)/kilogram (kg) every 2 weeks (Q2W).
|
Phase 1 Dose Escalation: SNDX-6352 0.5 mg/kg Q2W
Participants received an IV infusion of SNDX-6352 0.5 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 1 mg/kg Q2W
Participants received an IV infusion of SNDX-6352 1 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 3 mg/kg Q2W
Participants received an IV infusion of SNDX-6352 3 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 3 mg/kg Q4W
Participants received an IV infusion of SNDX-6352 3 mg/kg every 4 weeks (Q4W).
|
Phase 2 Dose Expansion: SNDX-6352 1 mg/kg Q2W
Participants received an IV infusion of SNDX-6352 1 mg/kg Q2W.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
3
|
6
|
7
|
23
|
|
Overall Study
Received at Least 1 Dose of Study Treatment
|
1
|
1
|
3
|
6
|
6
|
23
|
|
Overall Study
Dose-limiting Toxicity (DLT) Evaluable
|
1
|
1
|
3
|
6
|
6
|
0
|
|
Overall Study
COMPLETED
|
0
|
1
|
1
|
3
|
3
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
2
|
3
|
4
|
14
|
Reasons for withdrawal
| Measure |
Phase 1 Dose Escalation: SNDX-6352 0.15 mg/kg Q2W
Participants received an intravenous (IV) infusion of SNDX-6352 0.15 milligrams (mg)/kilogram (kg) every 2 weeks (Q2W).
|
Phase 1 Dose Escalation: SNDX-6352 0.5 mg/kg Q2W
Participants received an IV infusion of SNDX-6352 0.5 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 1 mg/kg Q2W
Participants received an IV infusion of SNDX-6352 1 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 3 mg/kg Q2W
Participants received an IV infusion of SNDX-6352 3 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 3 mg/kg Q4W
Participants received an IV infusion of SNDX-6352 3 mg/kg every 4 weeks (Q4W).
|
Phase 2 Dose Expansion: SNDX-6352 1 mg/kg Q2W
Participants received an IV infusion of SNDX-6352 1 mg/kg Q2W.
|
|---|---|---|---|---|---|---|
|
Overall Study
Investigator's Decision
|
0
|
0
|
0
|
1
|
0
|
7
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Overall Study
Progressive Disease
|
1
|
0
|
1
|
0
|
3
|
4
|
|
Overall Study
Difficulty Coming into Site
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Death
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Drug Intolerance
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Noncompliance with follow-up visit
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Not Treated
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Phase 1/2 Study to Evaluate Axatilimab in Participants With Active cGVHD
Baseline characteristics by cohort
| Measure |
Phase 1 Dose Escalation: SNDX-6352 0.15 mg/kg Q2W
n=1 Participants
Participants received an IV infusion of SNDX-6352 at 0.15 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 0.5 mg/kg Q2W
n=1 Participants
Participants received an IV infusion of SNDX-6352 0.5 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 1 mg/kg Q2W
n=3 Participants
Participants received an IV infusion of SNDX-6352 1 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 3 mg/kg Q2W
n=6 Participants
Participants received an IV infusion of SNDX-6352 3 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 3 mg/kg Q4W
n=6 Participants
Participants received an IV infusion of SNDX-6352 3 mg/kg Q4W.
|
Phase 2 Dose Expansion: SNDX-6352 1 mg/kg Q2W
n=23 Participants
Participants received an IV infusion of SNDX-6352 1 mg/kg Q2W.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
64.0 years
n=99 Participants
|
48.0 years
n=107 Participants
|
43.7 years
n=206 Participants
|
61.0 years
n=7 Participants
|
59.2 years
n=31 Participants
|
52.5 years
n=30 Participants
|
54.7 years
n=3 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
9 Participants
n=30 Participants
|
15 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
14 Participants
n=30 Participants
|
25 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
22 Participants
n=30 Participants
|
39 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
5 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
20 Participants
n=30 Participants
|
34 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Day 1 through the first 28 days from the first dose of SNDX-6352 or administration of the third dose (Cycle 2 Day 1), whichever is later (from Cycle 1 Day 1 to Cycle 2 Day 1)Population: Participants who received at least 1 cycle of treatment and had at least one post-baseline response assessment.
A DLT was defined as the occurrence of any protocol-specified event within the first 28 days from the first dose of SNDX-6352 or administration of the third dose (Cycle 2 Day 1), whichever is later (from Cycle 1 Day 1 to Cycle 2 Day 1) and assessed by the Investigator as not being definitely attributable to underlying disease, disease progression, inter-current illness, concomitant medications or any other alternative cause.
Outcome measures
| Measure |
Phase 1 Dose Escalation: SNDX-6352 0.15 mg/kg
n=1 Participants
Participants received an IV infusion of SNDX-6352 0.15 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 0.5 mg/kg
n=1 Participants
Participants received an IV infusion of SNDX-6352 0.5 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 1 mg/kg
n=3 Participants
Participants received an IV infusion of SNDX-6352 1 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 3 mg/kg
n=6 Participants
Participants received an IV infusion of SNDX-6352 3 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 3 mg/kg Q4W
n=6 Participants
Participants received an IV infusion of SNDX-6352 3 mg/kg Q4W.
|
|---|---|---|---|---|---|
|
Phase 1: Number of Participants With DLTs
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 through the first 28 days from the first dose of SNDX-6352 or administration of the third dose (Cycle 2 Day 1), whichever is later (from C1D1 to C2D1)Population: Participants who received at least 1 cycle of treatment and had at least one post-baseline response assessment in Phase 1.
The RP2D was determined in discussion with the Sponsor, Medical Monitor, and Dose Determination Phase Investigators and was based on observations from the Phase 1 of the study (clinical benefit in chronic graft versus host disease \[cGVHD\] and pharmacokinetic/pharmacodynamic effects).
Outcome measures
| Measure |
Phase 1 Dose Escalation: SNDX-6352 0.15 mg/kg
n=17 Participants
Participants received an IV infusion of SNDX-6352 0.15 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 0.5 mg/kg
Participants received an IV infusion of SNDX-6352 0.5 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 1 mg/kg
Participants received an IV infusion of SNDX-6352 1 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 3 mg/kg
Participants received an IV infusion of SNDX-6352 3 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 3 mg/kg Q4W
Participants received an IV infusion of SNDX-6352 3 mg/kg Q4W.
|
|---|---|---|---|---|---|
|
Phase 1: Recommended Phase 2 Dose (RP2D)
|
1 mg/kg
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycle 7 Day 1 (Day 168)Population: Safety Analysis Set: All participants who received at least 1 dose of study treatment.
CR or PR was defined by the 2014 National Institutes of Health (NIH) Consensus Development Project on Criteria for Clinical Trials in cGVHD.CR was defined as resolution of all manifestations in each organ or site, and PR was defined as improvement in at least 1 organ or site without progression in any other organ or site. ORR was defined as the percentage of participants achieving a best overall response of CR or PR .ORR calculated as: (number of participants with best overall response as CR or PR)/total number of participants.
Outcome measures
| Measure |
Phase 1 Dose Escalation: SNDX-6352 0.15 mg/kg
n=23 Participants
Participants received an IV infusion of SNDX-6352 0.15 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 0.5 mg/kg
Participants received an IV infusion of SNDX-6352 0.5 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 1 mg/kg
Participants received an IV infusion of SNDX-6352 1 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 3 mg/kg
Participants received an IV infusion of SNDX-6352 3 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 3 mg/kg Q4W
Participants received an IV infusion of SNDX-6352 3 mg/kg Q4W.
|
|---|---|---|---|---|---|
|
Phase 2: Overall Response Rate (ORR) as Assessed by the Number of Participants With Complete Response (CR) or Partial Response (PR) at Cycle 7 Day 1 (Day 168)
|
39.1 percentage of participants
Interval 19.71 to 61.46
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: predose, at 30 min (end of infusion), and at 1 hour and 8 hours on Day 1 and Day 15Population: Pharmacokinetic Analysis Set: All treated participants who had at least 1 plasma concentration measured. Number Analyzed = participants who were evaluable at specified timepoints
Blood samples were collected for determination of SNDX-6352 concentration.
Outcome measures
| Measure |
Phase 1 Dose Escalation: SNDX-6352 0.15 mg/kg
n=1 Participants
Participants received an IV infusion of SNDX-6352 0.15 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 0.5 mg/kg
n=1 Participants
Participants received an IV infusion of SNDX-6352 0.5 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 1 mg/kg
n=3 Participants
Participants received an IV infusion of SNDX-6352 1 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 3 mg/kg
n=6 Participants
Participants received an IV infusion of SNDX-6352 3 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 3 mg/kg Q4W
n=6 Participants
Participants received an IV infusion of SNDX-6352 3 mg/kg Q4W.
|
|---|---|---|---|---|---|
|
Phase 1: Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration for SNDX-6352
Cycle 1 Day 1
|
30.7 µg*h/mL
Interval 30.7 to 30.7
|
96.2 µg*h/mL
Interval 96.2 to 96.2
|
1546.0 µg*h/mL
Interval 898.0 to 2140.0
|
10263.3 µg*h/mL
Interval 4660.0 to 15300.0
|
12256.7 µg*h/mL
Interval 6760.0 to 20700.0
|
|
Phase 1: Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration for SNDX-6352
Cycle 1 Day 15
|
22.9 µg*h/mL
Interval 22.9 to 22.9
|
98.9 µg*h/mL
Interval 98.9 to 98.9
|
714.0 µg*h/mL
Interval 121.0 to 1740.0
|
14,055.0 µg*h/mL
Interval 575.0 to
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: predose, at 30 min (end of infusion), and at 1 hour and 8 hours on Day 1 and Day 15Population: Pharmacokinetic Analysis Set: All treated participants who had at least 1 plasma concentration measured. Number Analyzed = participants who were evaluable at specified timepoints
Blood samples were collected for determination of SNDX-6352 concentration.
Outcome measures
| Measure |
Phase 1 Dose Escalation: SNDX-6352 0.15 mg/kg
n=1 Participants
Participants received an IV infusion of SNDX-6352 0.15 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 0.5 mg/kg
n=1 Participants
Participants received an IV infusion of SNDX-6352 0.5 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 1 mg/kg
n=3 Participants
Participants received an IV infusion of SNDX-6352 1 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 3 mg/kg
n=6 Participants
Participants received an IV infusion of SNDX-6352 3 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 3 mg/kg Q4W
n=6 Participants
Participants received an IV infusion of SNDX-6352 3 mg/kg Q4W.
|
|---|---|---|---|---|---|
|
Phase 1: Observed Maximum Plasma Concentration for SNDX-6352
Cycle 1 Day 1
|
4.6 µg/mL
Interval 4.6 to 4.6
|
13.7 µg/mL
Interval 13.7 to 13.7
|
26.7 µg/mL
Interval 19.5 to 38.7
|
84.0 µg/mL
Interval 63.0 to 106.0
|
82.2 µg/mL
Interval 62.2 to 104.0
|
|
Phase 1: Observed Maximum Plasma Concentration for SNDX-6352
Cycle 1 Day 15
|
3.5 µg/mL
Interval 3.5 to 3.5
|
14.2 µg/mL
Interval 14.2 to 14.2
|
27.4 µg/mL
Interval 20.1 to 41.3
|
91.8 µg/mL
Interval 65.1 to 132.0
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: predose, at 30 min (end of infusion), and at 1 hour and 8 hours on Day 1 and Day 15Population: Pharmacokinetic Analysis Set: All treated participants who had at least 1 plasma concentration measured. Number Analyzed = participants who were evaluable at specified timepoints
Blood samples were collected for determination of SNDX-6352 concentration.
Outcome measures
| Measure |
Phase 1 Dose Escalation: SNDX-6352 0.15 mg/kg
n=1 Participants
Participants received an IV infusion of SNDX-6352 0.15 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 0.5 mg/kg
n=1 Participants
Participants received an IV infusion of SNDX-6352 0.5 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 1 mg/kg
n=3 Participants
Participants received an IV infusion of SNDX-6352 1 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 3 mg/kg
n=6 Participants
Participants received an IV infusion of SNDX-6352 3 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 3 mg/kg Q4W
n=6 Participants
Participants received an IV infusion of SNDX-6352 3 mg/kg Q4W.
|
|---|---|---|---|---|---|
|
Phase 1: Time to Observed Maximum Plasma Concentration
Cycle 1 Day 1
|
1.0 hours
Interval 1.0 to 1.0
|
1.5 hours
Interval 1.5 to 1.5
|
0.6 hours
Interval 0.6 to 0.6
|
0.9 hours
Interval 0.6 to 7.5
|
1.0 hours
Interval 0.5 to 7.9
|
|
Phase 1: Time to Observed Maximum Plasma Concentration
Cycle 1 Day 15
|
0.6 hours
Interval 0.6 to 0.6
|
0.5 hours
Interval 0.5 to 0.5
|
1.0 hours
Interval 0.6 to 1.5
|
1.0 hours
Interval 0.6 to 1.1
|
—
|
SECONDARY outcome
Timeframe: Baseline, Cycle 1 Day 8, Day 15, predose at Cycle 2 Day 1, Cycle 4 Day 1 (28-day cycles), and end of treatment (EOT) (median duration of treatment = 7 months)Population: Safety Analysis Set: All participants who received at least 1 dose of study treatment. Number Analyzed = participants who were evaluable at specified timepoints
Blood samples were collected for determination of serum concentrations.
Outcome measures
| Measure |
Phase 1 Dose Escalation: SNDX-6352 0.15 mg/kg
n=1 Participants
Participants received an IV infusion of SNDX-6352 0.15 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 0.5 mg/kg
n=1 Participants
Participants received an IV infusion of SNDX-6352 0.5 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 1 mg/kg
n=3 Participants
Participants received an IV infusion of SNDX-6352 1 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 3 mg/kg
n=6 Participants
Participants received an IV infusion of SNDX-6352 3 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 3 mg/kg Q4W
n=6 Participants
Participants received an IV infusion of SNDX-6352 3 mg/kg Q4W.
|
|---|---|---|---|---|---|
|
Phase 1: Changes From Baseline in Colony-Stimulating Factor-1 (CSF-1) and Interleukin (IL-34) Serum Concentrations
CSF-1 Cycle 1 Day 8
|
2.0 pg/mL
Interval 2.0 to 2.0
|
602.0 pg/mL
Interval 602.0 to 602.0
|
364480.0 pg/mL
Interval 211185.0 to 400666.0
|
544837.5 pg/mL
Interval 433627.0 to 613511.0
|
451482.0 pg/mL
Interval 366543.0 to 697378.0
|
|
Phase 1: Changes From Baseline in Colony-Stimulating Factor-1 (CSF-1) and Interleukin (IL-34) Serum Concentrations
CSF-1 Cycle 1 Day 15
|
69.0 pg/mL
Interval 69.0 to 69.0
|
-87.0 pg/mL
Interval -87.0 to -87.0
|
680.0 pg/mL
Interval -418.0 to 1556.0
|
897522.0 pg/mL
Interval 75411.0 to 966627.0
|
821180.5 pg/mL
Interval 581543.0 to 990015.0
|
|
Phase 1: Changes From Baseline in Colony-Stimulating Factor-1 (CSF-1) and Interleukin (IL-34) Serum Concentrations
CSF-1 Cycle 2 Day 1
|
19.0 pg/mL
Interval 19.0 to 19.0
|
227.0 pg/mL
Interval 227.0 to 227.0
|
400.0 pg/mL
Interval -126.0 to 60066.0
|
1474438.5 pg/mL
Interval 1439355.0 to 1509522.0
|
773476.0 pg/mL
Interval 11.0 to 1029015.0
|
|
Phase 1: Changes From Baseline in Colony-Stimulating Factor-1 (CSF-1) and Interleukin (IL-34) Serum Concentrations
CSF-1 Cycle 4 Day 1
|
—
|
229.0 pg/mL
Interval 229.0 to 229.0
|
465.0 pg/mL
Interval -319.0 to 1378480.0
|
899337.5 pg/mL
Interval -680.0 to 1799355.0
|
1386196.5 pg/mL
Interval 603378.0 to 2169015.0
|
|
Phase 1: Changes From Baseline in Colony-Stimulating Factor-1 (CSF-1) and Interleukin (IL-34) Serum Concentrations
CSF-1 EOT
|
63.0 pg/mL
Interval 63.0 to 63.0
|
—
|
—
|
—
|
1709787.0 pg/mL
Interval 1709787.0 to 1709787.0
|
|
Phase 1: Changes From Baseline in Colony-Stimulating Factor-1 (CSF-1) and Interleukin (IL-34) Serum Concentrations
IL-34 Cycle 1 Day 8
|
0 pg/mL
Interval 0.0 to 0.0
|
0 pg/mL
Interval 0.0 to 0.0
|
156.7 pg/mL
Interval 86.0 to 409.0
|
576.2 pg/mL
Interval 316.0 to 929.0
|
286.7 pg/mL
Interval 81.0 to 775.0
|
|
Phase 1: Changes From Baseline in Colony-Stimulating Factor-1 (CSF-1) and Interleukin (IL-34) Serum Concentrations
IL-34 Cycle 1 Day 15
|
0 pg/mL
Interval 0.0 to 0.0
|
0 pg/mL
Interval 0.0 to 0.0
|
0 pg/mL
Interval 0.0 to 0.0
|
690.7 pg/mL
Interval 199.0 to 1259.0
|
456.7 pg/mL
Interval 216.0 to 744.0
|
|
Phase 1: Changes From Baseline in Colony-Stimulating Factor-1 (CSF-1) and Interleukin (IL-34) Serum Concentrations
IL-34 Cycle 2 Day 1
|
0 pg/mL
Interval 0.0 to 0.0
|
0 pg/mL
Interval 0.0 to 0.0
|
0 pg/mL
Interval 0.0 to 42.0
|
1133.7 pg/mL
Interval 979.0 to 1289.0
|
190.7 pg/mL
Interval 0.0 to 931.0
|
|
Phase 1: Changes From Baseline in Colony-Stimulating Factor-1 (CSF-1) and Interleukin (IL-34) Serum Concentrations
IL-34 Cycle 4 Day 1
|
—
|
0 pg/mL
Interval 0.0 to 0.0
|
0 pg/mL
Interval 0.0 to 395.0
|
569.4 pg/mL
Interval 0.0 to 1139.0
|
533.7 pg/mL
Interval 241.0 to 827.0
|
|
Phase 1: Changes From Baseline in Colony-Stimulating Factor-1 (CSF-1) and Interleukin (IL-34) Serum Concentrations
IL-34 EOT
|
0 pg/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
676.7 pg/mL
Interval 676.7 to 676.7
|
SECONDARY outcome
Timeframe: Baseline, Day 8, Day 15, predose at Cycle 2 Day 1, Cycle 4 Day 1, and EOT (median duration of treatment = 7 months)Population: Safety Analysis Set: All participants who received at least 1 dose of study treatment. Number Analyzed = participants who were evaluable at specified timepoints
Blood samples were collected for determination nonclassical monocytes levels.
Outcome measures
| Measure |
Phase 1 Dose Escalation: SNDX-6352 0.15 mg/kg
Participants received an IV infusion of SNDX-6352 0.15 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 0.5 mg/kg
n=1 Participants
Participants received an IV infusion of SNDX-6352 0.5 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 1 mg/kg
n=2 Participants
Participants received an IV infusion of SNDX-6352 1 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 3 mg/kg
n=5 Participants
Participants received an IV infusion of SNDX-6352 3 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 3 mg/kg Q4W
n=6 Participants
Participants received an IV infusion of SNDX-6352 3 mg/kg Q4W.
|
|---|---|---|---|---|---|
|
Phase 1: Percent Change From Baseline in Nonclassical Monocytes (CD14+CD16++)
Cycle 1 Day 8
|
—
|
-41.7 percent change
Interval -41.7 to -41.7
|
-92.7 percent change
Interval -97.0 to -89.0
|
-95.7 percent change
Interval -98.0 to -90.0
|
-81.4 percent change
Interval -90.0 to -33.0
|
|
Phase 1: Percent Change From Baseline in Nonclassical Monocytes (CD14+CD16++)
Cycle 1 Day 15
|
—
|
-66.7 percent change
Interval -66.7 to -66.7
|
242.8 percent change
Interval -31.0 to 517.0
|
-96.5 percent change
Interval -98.0 to -94.0
|
-81.5 percent change
Interval -84.0 to 67.0
|
|
Phase 1: Percent Change From Baseline in Nonclassical Monocytes (CD14+CD16++)
Cycle 1 Day 22
|
—
|
—
|
—
|
—
|
-90.9 percent change
Interval -90.9 to -90.9
|
|
Phase 1: Percent Change From Baseline in Nonclassical Monocytes (CD14+CD16++)
Cycle 2 Day 1
|
—
|
-58.3 percent change
Interval -58.3 to -58.3
|
-31.0 percent change
Interval -31.0 to -31.0
|
-94.4 percent change
Interval -94.4 to -94.4
|
-67.5 percent change
Interval -81.0 to 167.0
|
|
Phase 1: Percent Change From Baseline in Nonclassical Monocytes (CD14+CD16++)
Cycle 4 Day 1
|
—
|
-16.7 percent change
Interval -16.7 to -16.7
|
273.5 percent change
Interval 41.0 to 506.0
|
-76.5 percent change
Interval -99.0 to -54.0
|
-82.5 percent change
Interval -91.0 to -74.0
|
|
Phase 1: Percent Change From Baseline in Nonclassical Monocytes (CD14+CD16++)
EOT
|
—
|
—
|
—
|
—
|
-75.0 percent change
Interval -75.0 to -75.0
|
SECONDARY outcome
Timeframe: Predose on Cycle 1 Day 1, Cycle 1 Day 15, Cycle 3 Day 1, Day 1 of each subsequent cycle through EOT plus 30 days after last dose (safety follow-up) (median duration of treatment = 7 months)Population: Safety Analysis Set: All participants who received at least 1 dose of study treatment.
Blood samples were collected for ADA assessment. A participant was considered ADA positive if at least 1 postbaseline sample was ADA positive.
Outcome measures
| Measure |
Phase 1 Dose Escalation: SNDX-6352 0.15 mg/kg
n=1 Participants
Participants received an IV infusion of SNDX-6352 0.15 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 0.5 mg/kg
n=1 Participants
Participants received an IV infusion of SNDX-6352 0.5 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 1 mg/kg
n=3 Participants
Participants received an IV infusion of SNDX-6352 1 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 3 mg/kg
n=6 Participants
Participants received an IV infusion of SNDX-6352 3 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 3 mg/kg Q4W
n=6 Participants
Participants received an IV infusion of SNDX-6352 3 mg/kg Q4W.
|
|---|---|---|---|---|---|
|
Phase 1: Number of Participants Positive for Anti-Drug Antibodies (ADA)
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 1 of each 28-Day cycle up to Cycle 7 Day 1Population: Safety Analysis Set: All participants who received at least 1 dose of study treatment.
Physician-reported global cGVHD activity assessment and cGVHD response determination. Best overall response was calculated as percent of participants with a response of CR or PR.
Outcome measures
| Measure |
Phase 1 Dose Escalation: SNDX-6352 0.15 mg/kg
n=23 Participants
Participants received an IV infusion of SNDX-6352 0.15 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 0.5 mg/kg
Participants received an IV infusion of SNDX-6352 0.5 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 1 mg/kg
Participants received an IV infusion of SNDX-6352 1 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 3 mg/kg
Participants received an IV infusion of SNDX-6352 3 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 3 mg/kg Q4W
Participants received an IV infusion of SNDX-6352 3 mg/kg Q4W.
|
|---|---|---|---|---|---|
|
Phase 2: Best Overall Response (BOR), as Defined by the 2014 NIH Consensus Development Project on Criteria for Clinical Trials in cGVHD
|
78.3 percentage of participants
Interval 56.3 to 92.54
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study intervention (Day 1) up to 27 monthsPopulation: Safety Analysis Set: All participants who received at least 1 dose of study treatment.
FFS was defined as the time from first dose of study intervention to unequivocal progression of cGVHD or relapse of underlying malignancy or addition of another systemic immune suppressive therapy or discontinuation of study treatment due to toxicity or death for any reason. Unequivocal progression of cGVHD is defined as treatment discontinuation due to clinical progression. The duration of FFS was evaluated using organ-specific cGVHD activity assessment form and and summarized descriptively using the Kaplan-Meier method.
Outcome measures
| Measure |
Phase 1 Dose Escalation: SNDX-6352 0.15 mg/kg
n=23 Participants
Participants received an IV infusion of SNDX-6352 0.15 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 0.5 mg/kg
Participants received an IV infusion of SNDX-6352 0.5 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 1 mg/kg
Participants received an IV infusion of SNDX-6352 1 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 3 mg/kg
Participants received an IV infusion of SNDX-6352 3 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 3 mg/kg Q4W
Participants received an IV infusion of SNDX-6352 3 mg/kg Q4W.
|
|---|---|---|---|---|---|
|
Phase 2: Failure Free Survival (FFS)
|
16.9 months
Interval 9.3 to
The upper confidence interval (CI) was not evaluable due to insufficient number of participants with events.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 of each 28-Day cycle for up to 12 cyclesPopulation: Participants who achieved PR or CR in the study were evaluable for DOR.
DOR was defined as the time of initial response until documented progression or start of another systemic treatment as assessed by the Kaplan-Meir method.
Outcome measures
| Measure |
Phase 1 Dose Escalation: SNDX-6352 0.15 mg/kg
n=18 Participants
Participants received an IV infusion of SNDX-6352 0.15 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 0.5 mg/kg
Participants received an IV infusion of SNDX-6352 0.5 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 1 mg/kg
Participants received an IV infusion of SNDX-6352 1 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 3 mg/kg
Participants received an IV infusion of SNDX-6352 3 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 3 mg/kg Q4W
Participants received an IV infusion of SNDX-6352 3 mg/kg Q4W.
|
|---|---|---|---|---|---|
|
Phase 2: Duration of Response (DOR)
|
9.53 months
Interval 1.87 to 17.05
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 of each 28-Day cycle for up to 12 cyclesPopulation: Safety Analysis Set: All participants who received at least 1 dose of study treatment.
SSR of CR or PR ≥20 weeks was defined as rate of CR or PR lasting for at least 20 weeks from the time of initial response.
Outcome measures
| Measure |
Phase 1 Dose Escalation: SNDX-6352 0.15 mg/kg
n=23 Participants
Participants received an IV infusion of SNDX-6352 0.15 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 0.5 mg/kg
Participants received an IV infusion of SNDX-6352 0.5 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 1 mg/kg
Participants received an IV infusion of SNDX-6352 1 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 3 mg/kg
Participants received an IV infusion of SNDX-6352 3 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 3 mg/kg Q4W
Participants received an IV infusion of SNDX-6352 3 mg/kg Q4W.
|
|---|---|---|---|---|---|
|
Phase 2: Sustained Response Rate (SRR)
|
39.1 percentage of participants
Interval 19.7 to 61.5
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 of each 28-Day cycle for up to 12 cyclesPopulation: Safety Analysis Set: All participants who received at least 1 dose of study treatment.
The percentage of participants with a response (CR/PR) in the skin, eyes, mouth, esophagus, upper gastrointestinal (GI), lower GI, liver, lungs, or joints and fascia were assessed using the NIH Consensus Development Project on Clinical Trials.
Outcome measures
| Measure |
Phase 1 Dose Escalation: SNDX-6352 0.15 mg/kg
n=23 Participants
Participants received an IV infusion of SNDX-6352 0.15 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 0.5 mg/kg
Participants received an IV infusion of SNDX-6352 0.5 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 1 mg/kg
Participants received an IV infusion of SNDX-6352 1 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 3 mg/kg
Participants received an IV infusion of SNDX-6352 3 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 3 mg/kg Q4W
Participants received an IV infusion of SNDX-6352 3 mg/kg Q4W.
|
|---|---|---|---|---|---|
|
Phase 2: Organ-specific Response Rate Based on 2014 NIH Consensus Development Project on Criteria for Clinical Trials in cGVHD
Esophagus
|
83.3 percentage of participants
Interval 35.88 to 99.58
|
—
|
—
|
—
|
—
|
|
Phase 2: Organ-specific Response Rate Based on 2014 NIH Consensus Development Project on Criteria for Clinical Trials in cGVHD
Eyes
|
18.8 percentage of participants
Interval 4.05 to 45.65
|
—
|
—
|
—
|
—
|
|
Phase 2: Organ-specific Response Rate Based on 2014 NIH Consensus Development Project on Criteria for Clinical Trials in cGVHD
Joints and Fascia
|
76.5 percentage of participants
Interval 50.1 to 93.19
|
—
|
—
|
—
|
—
|
|
Phase 2: Organ-specific Response Rate Based on 2014 NIH Consensus Development Project on Criteria for Clinical Trials in cGVHD
Liver
|
0 percentage of participants
Interval 0.0 to 70.76
|
—
|
—
|
—
|
—
|
|
Phase 2: Organ-specific Response Rate Based on 2014 NIH Consensus Development Project on Criteria for Clinical Trials in cGVHD
Lower GI
|
100.0 percentage of participants
Interval 39.76 to 100.0
|
—
|
—
|
—
|
—
|
|
Phase 2: Organ-specific Response Rate Based on 2014 NIH Consensus Development Project on Criteria for Clinical Trials in cGVHD
Lungs
|
33.3 percentage of participants
Interval 7.49 to 70.07
|
—
|
—
|
—
|
—
|
|
Phase 2: Organ-specific Response Rate Based on 2014 NIH Consensus Development Project on Criteria for Clinical Trials in cGVHD
Mouth
|
75.0 percentage of participants
Interval 42.81 to 94.51
|
—
|
—
|
—
|
—
|
|
Phase 2: Organ-specific Response Rate Based on 2014 NIH Consensus Development Project on Criteria for Clinical Trials in cGVHD
Skin
|
19.0 percentage of participants
Interval 5.45 to 41.91
|
—
|
—
|
—
|
—
|
|
Phase 2: Organ-specific Response Rate Based on 2014 NIH Consensus Development Project on Criteria for Clinical Trials in cGVHD
Upper GI
|
100.0 percentage of participants
Interval 39.76 to 100.0
|
—
|
—
|
—
|
—
|
|
Phase 2: Organ-specific Response Rate Based on 2014 NIH Consensus Development Project on Criteria for Clinical Trials in cGVHD
Global
|
47.8 percentage of participants
Interval 26.82 to 69.41
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 of each 28-Day cycle for up to 12 cyclesPopulation: Safety Analysis Set: All participants who received at least 1 dose of study treatment and who had this assessment.
Outcome measures
| Measure |
Phase 1 Dose Escalation: SNDX-6352 0.15 mg/kg
n=17 Participants
Participants received an IV infusion of SNDX-6352 0.15 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 0.5 mg/kg
Participants received an IV infusion of SNDX-6352 0.5 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 1 mg/kg
Participants received an IV infusion of SNDX-6352 1 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 3 mg/kg
Participants received an IV infusion of SNDX-6352 3 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 3 mg/kg Q4W
Participants received an IV infusion of SNDX-6352 3 mg/kg Q4W.
|
|---|---|---|---|---|---|
|
Phase 2: Number of Participants With a Joint and Fascia Response Based on Refined NIH Response Algorithm for cGVHD
Improved
|
10 Participants
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With a Joint and Fascia Response Based on Refined NIH Response Algorithm for cGVHD
Stable
|
7 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 of each 28-Day cycle for up to 12 cyclesPopulation: Safety Analysis Set: All participants who received at least 1 dose of study treatment.
The Lee cGVHD symptom questionnaire asked participants to indicate the degree of "bother" that they experienced during the past 7 days due to symptoms in 7 domains potentially affected by chronic GVHD (skin, eyes and mouth, breathing, eating and digestion, muscles and joints, energy, emotional distress) using a 5-point Likert scale from 0 "not at all" to 4 "extremely." Scores were normalized (0 to 100 scale) and the number of participants with a ≥ 7-point decrease in normalized score was calculated. A decrease in score indicated improvement in symptoms.
Outcome measures
| Measure |
Phase 1 Dose Escalation: SNDX-6352 0.15 mg/kg
n=22 Participants
Participants received an IV infusion of SNDX-6352 0.15 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 0.5 mg/kg
Participants received an IV infusion of SNDX-6352 0.5 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 1 mg/kg
Participants received an IV infusion of SNDX-6352 1 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 3 mg/kg
Participants received an IV infusion of SNDX-6352 3 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 3 mg/kg Q4W
Participants received an IV infusion of SNDX-6352 3 mg/kg Q4W.
|
|---|---|---|---|---|---|
|
Phase 2: Number of Participants With A Lee Symptom Scale Summary Score Decrease of at Least 7 Points From Baseline
|
12 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 of each 28-Day cycle for up to 12 cyclesPopulation: Safety Analysis Set: All participants who received at least 1 dose of study treatment and had corticosteroid usage at Cycle 1 Day 1.
Outcome measures
| Measure |
Phase 1 Dose Escalation: SNDX-6352 0.15 mg/kg
n=19 Participants
Participants received an IV infusion of SNDX-6352 0.15 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 0.5 mg/kg
Participants received an IV infusion of SNDX-6352 0.5 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 1 mg/kg
Participants received an IV infusion of SNDX-6352 1 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 3 mg/kg
Participants received an IV infusion of SNDX-6352 3 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 3 mg/kg Q4W
Participants received an IV infusion of SNDX-6352 3 mg/kg Q4W.
|
|---|---|---|---|---|---|
|
Phase 2: Number of Participants With a ≥50% Reduction in Prednisone Equivalent Dosage Lasting at Least 28 Days
|
5 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 of each 28-Day cycle for up to 12 cyclesPopulation: Safety Analysis Set: All participants who received at least 1 dose of study treatment and had calcineurin inhibitors usage at Cycle 1 Day 1.
Outcome measures
| Measure |
Phase 1 Dose Escalation: SNDX-6352 0.15 mg/kg
n=6 Participants
Participants received an IV infusion of SNDX-6352 0.15 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 0.5 mg/kg
Participants received an IV infusion of SNDX-6352 0.5 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 1 mg/kg
Participants received an IV infusion of SNDX-6352 1 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 3 mg/kg
Participants received an IV infusion of SNDX-6352 3 mg/kg Q2W.
|
Phase 1 Dose Escalation: SNDX-6352 3 mg/kg Q4W
Participants received an IV infusion of SNDX-6352 3 mg/kg Q4W.
|
|---|---|---|---|---|---|
|
Phase 2: Number of Participants Who Discontinued Calcineurin Inhibitor Use
|
0 Participants
|
—
|
—
|
—
|
—
|
Adverse Events
SNDX-6352 0.15 mg/kg Q2W
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
SNDX-6352 0.5 mg/kg Q2W
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
SNDX-6352 1 mg/kg Q2W
Serious events: 12 serious events
Other events: 26 other events
Deaths: 1 deaths
SNDX-6352 3 mg/kg Q2W
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
SNDX-6352 3 mg/kg Q4W
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SNDX-6352 0.15 mg/kg Q2W
n=1 participants at risk
Participants received an IV infusion of SNDX-6352 0.15 mg/kg Q2W in Phase 1.
|
SNDX-6352 0.5 mg/kg Q2W
n=1 participants at risk
Participants received an IV infusion of SNDX-6352 0.5 mg/kg Q2W in Phase 1.
|
SNDX-6352 1 mg/kg Q2W
n=26 participants at risk
Participants received an IV infusion of SNDX-6352 1 mg/kg Q2W in Phases 1 and 2.
|
SNDX-6352 3 mg/kg Q2W
n=6 participants at risk
Participants received an IV infusion of SNDX-6352 3 mg/kg Q2W in Phase 1.
|
SNDX-6352 3 mg/kg Q4W
n=6 participants at risk
Participants received an IV infusion of SNDX-6352 3 mg/kg Q4W in Phase 1.
|
|---|---|---|---|---|---|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Hepatobiliary disorders
Hepatitis
|
100.0%
1/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
100.0%
1/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
11.5%
3/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
General disorders
Face oedema
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
General disorders
Fatigue
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Infections and infestations
Influenza
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Infections and infestations
Klebsiella infection
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Infections and infestations
Metapneumovirus infection
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
General disorders
Oedema peripheral
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Infections and infestations
Sepsis
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Infections and infestations
Septic arthritis staphylococcal
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Infections and infestations
Septic shock
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
100.0%
1/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Infections and infestations
Wound infection pseudomonas
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Infections and infestations
Serratia sepsis
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
Other adverse events
| Measure |
SNDX-6352 0.15 mg/kg Q2W
n=1 participants at risk
Participants received an IV infusion of SNDX-6352 0.15 mg/kg Q2W in Phase 1.
|
SNDX-6352 0.5 mg/kg Q2W
n=1 participants at risk
Participants received an IV infusion of SNDX-6352 0.5 mg/kg Q2W in Phase 1.
|
SNDX-6352 1 mg/kg Q2W
n=26 participants at risk
Participants received an IV infusion of SNDX-6352 1 mg/kg Q2W in Phases 1 and 2.
|
SNDX-6352 3 mg/kg Q2W
n=6 participants at risk
Participants received an IV infusion of SNDX-6352 3 mg/kg Q2W in Phase 1.
|
SNDX-6352 3 mg/kg Q4W
n=6 participants at risk
Participants received an IV infusion of SNDX-6352 3 mg/kg Q4W in Phase 1.
|
|---|---|---|---|---|---|
|
General disorders
Fatigue
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
100.0%
1/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
46.2%
12/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
50.0%
3/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
33.3%
2/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
General disorders
Oedema peripheral
|
100.0%
1/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
15.4%
4/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
33.3%
2/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
7.7%
2/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
50.0%
3/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
General disorders
Chills
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
50.0%
3/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
General disorders
Malaise
|
100.0%
1/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
33.3%
2/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
General disorders
Gait disturbance
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
General disorders
Influenza like illness
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
General disorders
Oedema
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
7.7%
2/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
General disorders
Pain
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
General disorders
Axillary pain
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
General disorders
Chest discomfort
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
General disorders
Feeling abnormal
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
General disorders
Injection site reaction
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
General disorders
Swelling face
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Investigations
Aspartate aminotransferase increased
|
100.0%
1/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
23.1%
6/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
66.7%
4/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
66.7%
4/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
11.5%
3/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
100.0%
6/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
83.3%
5/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Investigations
Alanine aminotransferase increased
|
100.0%
1/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
19.2%
5/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
66.7%
4/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
50.0%
3/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
100.0%
1/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
15.4%
4/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
66.7%
4/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
50.0%
3/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Investigations
Amylase increased
|
100.0%
1/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
23.1%
6/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
66.7%
4/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Investigations
Lipase increased
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
15.4%
4/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
50.0%
3/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
50.0%
3/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
19.2%
5/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
33.3%
2/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
33.3%
2/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Investigations
Gamma-glutamyltransferase increased
|
100.0%
1/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
7.7%
2/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Investigations
Blood alkaline phosphatase increased
|
100.0%
1/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
7.7%
2/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Investigations
Weight decreased
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Investigations
White blood cell count decreased
|
100.0%
1/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Investigations
Blood creatine phosphokinase abnormal
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Investigations
C-reactive protein
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Investigations
Platelet count decreased
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Investigations
Red blood cell sedimentation rate increased
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Investigations
Vitamin B1 decreased
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
7.7%
2/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
33.3%
2/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
33.3%
2/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
11.5%
3/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
33.3%
2/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
11.5%
3/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
11.5%
3/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
33.3%
2/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
11.5%
3/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
100.0%
1/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
7.7%
2/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
7.7%
2/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
33.3%
2/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
11.5%
3/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Metabolism and nutrition disorders
Hyperammonaemia
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
1/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
100.0%
1/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
30.8%
8/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
66.7%
4/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
30.8%
8/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
50.0%
3/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
100.0%
1/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
11.5%
3/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
7.7%
2/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
33.3%
2/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
7.7%
2/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
7.7%
2/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
7.7%
2/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Gastrointestinal disorders
Abdominal distension
|
100.0%
1/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
7.7%
2/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Gastrointestinal disorders
Oral disorder
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Gastrointestinal disorders
Tongue erythema
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
26.9%
7/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Infections and infestations
COVID-19
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Infections and infestations
Conjunctivitis
|
100.0%
1/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Infections and infestations
Pustule
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
7.7%
2/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Infections and infestations
Eye infection
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Infections and infestations
Klebsiella infection
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Infections and infestations
Otitis externa
|
100.0%
1/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Infections and infestations
Paronychia
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Infections and infestations
Skin infection
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Infections and infestations
Wound infection pseudomonas
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
15.4%
4/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
33.3%
2/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
15.4%
4/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
33.3%
2/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
7.7%
2/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
33.3%
2/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
11.5%
3/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
11.5%
3/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
33.3%
2/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Musculoskeletal and connective tissue disorders
Abscess neck
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
100.0%
1/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
11.5%
3/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
11.5%
3/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
7.7%
2/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
100.0%
1/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
11.5%
3/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
33.3%
2/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
50.0%
3/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Eye disorders
Vision blurred
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
11.5%
3/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Eye disorders
Diplopia
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
7.7%
2/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Eye disorders
Eye pain
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
7.7%
2/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Eye disorders
Cataract
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Eye disorders
Eye irritation
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
7.7%
2/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Eye disorders
Photophobia
|
100.0%
1/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Nervous system disorders
Dizziness
|
100.0%
1/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
23.1%
6/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
50.0%
3/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
100.0%
1/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
19.2%
5/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
50.0%
3/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Nervous system disorders
Neuropathy peripheral
|
100.0%
1/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
7.7%
2/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
7.7%
2/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Psychiatric disorders
Insomnia
|
100.0%
1/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
15.4%
4/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
7.7%
2/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
7.7%
2/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Psychiatric disorders
Depression
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
100.0%
1/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
11.5%
3/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
33.3%
2/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
7.7%
2/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
100.0%
1/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
100.0%
1/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
15.4%
4/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
33.3%
2/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
15.4%
4/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
11.5%
3/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
7.7%
2/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Injury, poisoning and procedural complications
Procedural headache
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
11.5%
3/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
33.3%
2/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
33.3%
2/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Vascular disorders
Haematoma
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Vascular disorders
Flushing
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Vascular disorders
Hot flush
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Renal and urinary disorders
Chromaturia
|
100.0%
1/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Renal and urinary disorders
Urethral prolapse
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Endocrine disorders
Androgen deficiency
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
3.8%
1/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
|
Vascular disorders
Varicose vein
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/1 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/26 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
16.7%
1/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
0.00%
0/6 • From first dose of study drug up to EOT plus 90 days after last dose (safety follow-up) (median duration of treatment = 7 months)
Per pre-specified analysis, deaths and adverse events were collected by dose group. Therefore, data for participants who received dose group SNDX-6352 1 mg/kg Q2W in Phase 1 and Phase 2 are combined.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place