Trial Outcomes & Findings for TTX-030 in Combination With Immunotherapy and/or Chemotherapy in Subjects With Advanced Cancers (NCT NCT04306900)
NCT ID: NCT04306900
Last Updated: 2025-07-29
Results Overview
A DLT was defined as the occurrence of any of the following toxicities within the DLT Evaluation Period if judged by the Investigator and Sponsor to be possibly, probably, or definitely related to TTX-030 or budigalimab.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
185 participants
Primary outcome timeframe
7 day load + 1 cycle (1 cycle is 28 days)
Results posted on
2025-07-29
Participant Flow
Participant milestones
| Measure |
Cohort 1 - Safety Lead-in (TTX-030 + Budigalimab + mFOLFOX6)
Participants in Cohort 1 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
|
Cohort 3B - Gastric (TTX-030 + Budigalimab + mFOLFOX6)
Participants in Cohort 3B were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
|
Cohort 12 - Gastric (Budigalimab + mFOLFOX6)
Participants in Cohort 12 were administered IV budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
|
Cohort 3A - Gastric (TTX-030 + mFOLFOX6)
Participants in Cohort 3A were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
|
Cohort 2 - mCRPC (TTX-030 + Budigalimab + Docetaxel)
Participants in Safety Lead-in Cohort 2 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab 375 mg Q3W plus docetaxel at a dose of 75 mg/m2 Q3W on Day 1 of each 21-day treatment cycle.
|
Cohort 9 - Pancreatic (TTX-030 + Budigalimab + Gemcitabine + Nab-Paclitaxel)
Participants in Cohort 9 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
|
Cohort 11 - Pancreatic (TTX-030 + Gemcitabine + Nab-Paclitaxel)
Participants in Cohort 11 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
|
Cohort 4 - CRC (TTX-030 + Budigalimab)
Participants in Cohort 4 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
|
Cohort 6 - HNSCC (TTX-030 + Budigalimab)
Participants in Cohort 6 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
|
Cohort 8 - GEC (TTX-030 + Budigalimab)
Participants in Cohort 8 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
|
Cohort 10 - UCC (TTX-030 + Pembrolizumab)
Participants in Cohort 10 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus pembrolizumab at a dose of 200 mg Q3W on Day 1 of each 21-day treatment cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
44
|
25
|
6
|
7
|
28
|
17
|
14
|
5
|
23
|
8
|
|
Overall Study
COMPLETED
|
8
|
44
|
25
|
6
|
7
|
28
|
17
|
14
|
5
|
23
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
TTX-030 in Combination With Immunotherapy and/or Chemotherapy in Subjects With Advanced Cancers
Baseline characteristics by cohort
| Measure |
Cohort 10 - UCC (TTX-030 + Pembrolizumab)
n=8 Participants
Participants in Cohort 10 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus pembrolizumab at a dose of 200 mg Q3W on Day 1 of each 21-day treatment cycle.
|
Total
n=185 Participants
Total of all reporting groups
|
Cohort 1 - Safety Lead-in (TTX-030 + Budigalimab + mFOLFOX6)
n=8 Participants
Participants in Cohort 1 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
|
Cohort 3B - Gastric (TTX-030 + Budigalimab + mFOLFOX6)
n=44 Participants
Participants in Cohort 3B were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
|
Cohort 12 - Gastric (Budigalimab + mFOLFOX6
n=25 Participants
Participants in Cohort 12 were administered IV budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
|
Cohort 3A - Gastric (TTX-030 + mFOLFOX6)
n=6 Participants
Participants in Cohort 3A were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
|
Cohort 2 - mCRPC (TTX-030 + Budigalimab + Docetaxel)
n=7 Participants
Participants in Safety Lead-in Cohort 2 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab 375 mg Q3W plus docetaxel at a dose of 75 mg/m2 Q3W on Day 1 of each 21-day treatment cycle.
|
Cohort 9 - Pancreatic (TTX-030 + Budigalimab + Gemcitabine + Nab-Paclitaxel)
n=28 Participants
Participants in Cohort 9 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
|
Cohort 11 - Pancreatic (TTX-030 + Gemcitabine + Nab-Paclitaxel)
n=17 Participants
Participants in Cohort 11 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
|
Cohort 4 - CRC (TTX-030 + Budigalimab)
n=14 Participants
Participants in Cohort 4 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
|
Cohort 6 - HNSCC (TTX-030 + Budigalimab)
n=5 Participants
Participants in Cohort 6 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
|
Cohort 8 - GEC (TTX-030 + Budigalimab)
n=23 Participants
Participants in Cohort 8 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=17 Participants
|
102 Participants
n=21 Participants
|
4 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
9 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
12 Participants
n=64 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=17 Participants
|
83 Participants
n=21 Participants
|
4 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
16 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
5 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
11 Participants
n=64 Participants
|
|
Age, Continuous
|
66.4 years
STANDARD_DEVIATION 7.42 • n=17 Participants
|
63.1 years
STANDARD_DEVIATION 10.77 • n=21 Participants
|
65.9 years
STANDARD_DEVIATION 9.40 • n=5 Participants
|
59.5 years
STANDARD_DEVIATION 12.51 • n=7 Participants
|
63.2 years
STANDARD_DEVIATION 8.70 • n=5 Participants
|
62.5 years
STANDARD_DEVIATION 6.28 • n=4 Participants
|
65.7 years
STANDARD_DEVIATION 7.95 • n=21 Participants
|
65.7 years
STANDARD_DEVIATION 6.83 • n=10 Participants
|
68.2 years
STANDARD_DEVIATION 9.5 • n=115 Participants
|
61.4 years
STANDARD_DEVIATION 10.57 • n=6 Participants
|
65.2 years
STANDARD_DEVIATION 6.57 • n=6 Participants
|
61 years
STANDARD_DEVIATION 15.54 • n=64 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=17 Participants
|
57 Participants
n=21 Participants
|
2 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
13 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
5 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
8 Participants
n=64 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=17 Participants
|
128 Participants
n=21 Participants
|
6 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
15 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
9 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
15 Participants
n=64 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=17 Participants
|
69 Participants
n=21 Participants
|
0 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=17 Participants
|
9 Participants
n=21 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=64 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=17 Participants
|
99 Participants
n=21 Participants
|
7 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
16 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
10 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
17 Participants
n=64 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=17 Participants
|
8 Participants
n=21 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=64 Participants
|
|
Region of Enrollment
South Korea
|
3 Participants
n=17 Participants
|
61 Participants
n=21 Participants
|
0 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=17 Participants
|
124 Participants
n=21 Participants
|
8 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
20 Participants
n=10 Participants
|
15 Participants
n=115 Participants
|
14 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
23 Participants
n=64 Participants
|
PRIMARY outcome
Timeframe: 7 day load + 1 cycle (1 cycle is 28 days)Population: Only Cohort 1 and Cohort 2 are the safety lead-in cohorts and were evaluated for DLTs.
A DLT was defined as the occurrence of any of the following toxicities within the DLT Evaluation Period if judged by the Investigator and Sponsor to be possibly, probably, or definitely related to TTX-030 or budigalimab.
Outcome measures
| Measure |
Cohort 10 - UCC (TTX-030 + Pembrolizumab)
Participants in Cohort 10 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus pembrolizumab at a dose of 200 mg Q3W on Day 1 of each 21-day treatment cycle.
|
Cohort 1 - Safety Lead-in (TTX-030 + Budigalimab + mFOLFOX6)
n=6 Participants
Participants in Cohort 1 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
|
Cohort 3B - Gastric (TTX-030 + Budigalimab + mFOLFOX6)
Participants in Cohort 3B were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
|
Cohort 12 - Gastric (Budigalimab + mFOLFOX6)
Participants in Cohort 12 were administered IV budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
|
Cohort 3A - Gastric (TTX-030 + mFOLFOX6)
Participants in Cohort 3A were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
|
Cohort 2 - mCRPC (TTX-030 + Budigalimab + Docetaxel)
n=7 Participants
Participants in Safety Lead-in Cohort 2 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab 375mg Q3W plus docetaxel at a dose of 75 mg/m2 Q3W on Day 1 of each 21-day treatment cycle.
|
Cohort 9 - Pancreatic (TTX-030 + Budigalimab + Gemcitabine + Nab-Paclitaxel)
Participants in Cohort 9 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
|
Cohort 11 - Pancreatic (TTX-030 + Gemcitabine + Nab-Paclitaxel)
Participants in Cohort 11 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
|
Cohort 4 - CRC (TTX-030 + Budigalimab)
Participants in Cohort 4 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
|
Cohort 6 - HNSCC (TTX-030 + Budigalimab)
Participants in Cohort 6 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
|
Cohort 8 - GEC (TTX-030 + Budigalimab)
Participants in Cohort 8 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
|
0 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
7 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Through study completion, an average of 1 yearPopulation: This set included all participants who received at least 1 dose or any partial dose of study treatment. The Safety Analysis Set was used for safety endpoints and study treatment administration.
Number of study subjects experiencing adverse events (AEs) and serious adverse events (SAEs). Safety profile will be assessed through laboratory evaluations, vital signs, and physical examinations.
Outcome measures
| Measure |
Cohort 10 - UCC (TTX-030 + Pembrolizumab)
n=8 Participants
Participants in Cohort 10 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus pembrolizumab at a dose of 200 mg Q3W on Day 1 of each 21-day treatment cycle.
|
Cohort 1 - Safety Lead-in (TTX-030 + Budigalimab + mFOLFOX6)
n=8 Participants
Participants in Cohort 1 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
|
Cohort 3B - Gastric (TTX-030 + Budigalimab + mFOLFOX6)
n=44 Participants
Participants in Cohort 3B were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
|
Cohort 12 - Gastric (Budigalimab + mFOLFOX6)
n=25 Participants
Participants in Cohort 12 were administered IV budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
|
Cohort 3A - Gastric (TTX-030 + mFOLFOX6)
n=6 Participants
Participants in Cohort 3A were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
|
Cohort 2 - mCRPC (TTX-030 + Budigalimab + Docetaxel)
n=7 Participants
Participants in Safety Lead-in Cohort 2 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab 375mg Q3W plus docetaxel at a dose of 75 mg/m2 Q3W on Day 1 of each 21-day treatment cycle.
|
Cohort 9 - Pancreatic (TTX-030 + Budigalimab + Gemcitabine + Nab-Paclitaxel)
n=28 Participants
Participants in Cohort 9 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
|
Cohort 11 - Pancreatic (TTX-030 + Gemcitabine + Nab-Paclitaxel)
n=17 Participants
Participants in Cohort 11 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
|
Cohort 4 - CRC (TTX-030 + Budigalimab)
n=14 Participants
Participants in Cohort 4 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
|
Cohort 6 - HNSCC (TTX-030 + Budigalimab)
n=5 Participants
Participants in Cohort 6 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
|
Cohort 8 - GEC (TTX-030 + Budigalimab)
n=23 Participants
Participants in Cohort 8 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Incident of Adverse Events
|
8 Participants
|
8 Participants
|
44 Participants
|
25 Participants
|
6 Participants
|
7 Participants
|
28 Participants
|
17 Participants
|
14 Participants
|
5 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1 yearPopulation: The ORR was defined as the proportion of participants who achieved a BOR of either CR or PR as derived based on the lesion measurement provided by the Investigator per RECIST v1.1. Confirmed ORR was defined as 2 disease response assessments showing objective response (CR or PR) at least 4 weeks apart and was presented with corresponding 2-sided 95% confidence intervals (CIs) based on the Clopper-Pearson method.
ORR is defined as the proportion of subjects with CR or PR.
Outcome measures
| Measure |
Cohort 10 - UCC (TTX-030 + Pembrolizumab)
n=8 Participants
Participants in Cohort 10 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus pembrolizumab at a dose of 200 mg Q3W on Day 1 of each 21-day treatment cycle.
|
Cohort 1 - Safety Lead-in (TTX-030 + Budigalimab + mFOLFOX6)
n=7 Participants
Participants in Cohort 1 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
|
Cohort 3B - Gastric (TTX-030 + Budigalimab + mFOLFOX6)
n=41 Participants
Participants in Cohort 3B were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
|
Cohort 12 - Gastric (Budigalimab + mFOLFOX6)
n=23 Participants
Participants in Cohort 12 were administered IV budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
|
Cohort 3A - Gastric (TTX-030 + mFOLFOX6)
n=4 Participants
Participants in Cohort 3A were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
|
Cohort 2 - mCRPC (TTX-030 + Budigalimab + Docetaxel)
n=3 Participants
Participants in Safety Lead-in Cohort 2 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab 375mg Q3W plus docetaxel at a dose of 75 mg/m2 Q3W on Day 1 of each 21-day treatment cycle.
|
Cohort 9 - Pancreatic (TTX-030 + Budigalimab + Gemcitabine + Nab-Paclitaxel)
n=27 Participants
Participants in Cohort 9 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
|
Cohort 11 - Pancreatic (TTX-030 + Gemcitabine + Nab-Paclitaxel)
n=17 Participants
Participants in Cohort 11 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
|
Cohort 4 - CRC (TTX-030 + Budigalimab)
n=12 Participants
Participants in Cohort 4 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
|
Cohort 6 - HNSCC (TTX-030 + Budigalimab)
n=5 Participants
Participants in Cohort 6 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
|
Cohort 8 - GEC (TTX-030 + Budigalimab)
n=22 Participants
Participants in Cohort 8 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Confirmed Objective Response Rate (ORR)
|
12.5 percentage of participants
Interval 0.3 to 52.7
|
14.3 percentage of participants
Interval 0.4 to 57.9
|
56.1 percentage of participants
Interval 39.7 to 71.5
|
69.6 percentage of participants
Interval 47.1 to 86.8
|
75.0 percentage of participants
Interval 19.4 to 99.4
|
0 percentage of participants
Interval 0.0 to 41.0
|
33.3 percentage of participants
Interval 16.5 to 54.0
|
23.5 percentage of participants
Interval 6.8 to 49.9
|
0.0 percentage of participants
Interval 0.0 to 26.5
|
0.0 percentage of participants
Interval 0.0 to 52.2
|
9.1 percentage of participants
Interval 1.1 to 29.2
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1 yearThe BOR was defined as the best response (in the order of CR, PR, stable disease, and PD) by RECIST 1.1 documented from first dose until the end of study, first disease progression, death, or start of new anticancer therapy, whichever was earliest.
Outcome measures
| Measure |
Cohort 10 - UCC (TTX-030 + Pembrolizumab)
n=8 Participants
Participants in Cohort 10 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus pembrolizumab at a dose of 200 mg Q3W on Day 1 of each 21-day treatment cycle.
|
Cohort 1 - Safety Lead-in (TTX-030 + Budigalimab + mFOLFOX6)
n=7 Participants
Participants in Cohort 1 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
|
Cohort 3B - Gastric (TTX-030 + Budigalimab + mFOLFOX6)
n=41 Participants
Participants in Cohort 3B were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
|
Cohort 12 - Gastric (Budigalimab + mFOLFOX6)
n=23 Participants
Participants in Cohort 12 were administered IV budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
|
Cohort 3A - Gastric (TTX-030 + mFOLFOX6)
n=4 Participants
Participants in Cohort 3A were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
|
Cohort 2 - mCRPC (TTX-030 + Budigalimab + Docetaxel)
n=7 Participants
Participants in Safety Lead-in Cohort 2 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab 375mg Q3W plus docetaxel at a dose of 75 mg/m2 Q3W on Day 1 of each 21-day treatment cycle.
|
Cohort 9 - Pancreatic (TTX-030 + Budigalimab + Gemcitabine + Nab-Paclitaxel)
n=27 Participants
Participants in Cohort 9 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
|
Cohort 11 - Pancreatic (TTX-030 + Gemcitabine + Nab-Paclitaxel)
n=17 Participants
Participants in Cohort 11 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
|
Cohort 4 - CRC (TTX-030 + Budigalimab)
n=12 Participants
Participants in Cohort 4 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
|
Cohort 6 - HNSCC (TTX-030 + Budigalimab)
n=5 Participants
Participants in Cohort 6 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
|
Cohort 8 - GEC (TTX-030 + Budigalimab)
n=22 Participants
Participants in Cohort 8 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Best Response (BOR)
CR
|
1 Participants
|
0 Participants
|
5 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Best Response (BOR)
PR
|
0 Participants
|
1 Participants
|
18 Participants
|
14 Participants
|
3 Participants
|
0 Participants
|
9 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Best Response (BOR)
Stable Disease
|
2 Participants
|
2 Participants
|
14 Participants
|
6 Participants
|
0 Participants
|
7 Participants
|
13 Participants
|
10 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
|
Best Response (BOR)
PD
|
5 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
8 Participants
|
1 Participants
|
11 Participants
|
|
Best Response (BOR)
NE
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1 yearPopulation: Number (%) of subjects with events (PFS)
DoR will be defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.
Outcome measures
| Measure |
Cohort 10 - UCC (TTX-030 + Pembrolizumab)
Participants in Cohort 10 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus pembrolizumab at a dose of 200 mg Q3W on Day 1 of each 21-day treatment cycle.
|
Cohort 1 - Safety Lead-in (TTX-030 + Budigalimab + mFOLFOX6)
n=23 Participants
Participants in Cohort 1 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
|
Cohort 3B - Gastric (TTX-030 + Budigalimab + mFOLFOX6)
n=16 Participants
Participants in Cohort 3B were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
|
Cohort 12 - Gastric (Budigalimab + mFOLFOX6)
n=3 Participants
Participants in Cohort 12 were administered IV budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
|
Cohort 3A - Gastric (TTX-030 + mFOLFOX6)
n=9 Participants
Participants in Cohort 3A were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
|
Cohort 2 - mCRPC (TTX-030 + Budigalimab + Docetaxel)
n=4 Participants
Participants in Safety Lead-in Cohort 2 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab 375mg Q3W plus docetaxel at a dose of 75 mg/m2 Q3W on Day 1 of each 21-day treatment cycle.
|
Cohort 9 - Pancreatic (TTX-030 + Budigalimab + Gemcitabine + Nab-Paclitaxel)
n=2 Participants
Participants in Cohort 9 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
|
Cohort 11 - Pancreatic (TTX-030 + Gemcitabine + Nab-Paclitaxel)
n=1 Participants
Participants in Cohort 11 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
|
Cohort 4 - CRC (TTX-030 + Budigalimab)
Participants in Cohort 4 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
|
Cohort 6 - HNSCC (TTX-030 + Budigalimab)
Participants in Cohort 6 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
|
Cohort 8 - GEC (TTX-030 + Budigalimab)
Participants in Cohort 8 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Response (DOR)
|
—
|
13 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1 yearDCR is defined as the proportion of subjects with CR, PR, or SD per RECIST 1.1
Outcome measures
| Measure |
Cohort 10 - UCC (TTX-030 + Pembrolizumab)
n=8 Participants
Participants in Cohort 10 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus pembrolizumab at a dose of 200 mg Q3W on Day 1 of each 21-day treatment cycle.
|
Cohort 1 - Safety Lead-in (TTX-030 + Budigalimab + mFOLFOX6)
n=7 Participants
Participants in Cohort 1 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
|
Cohort 3B - Gastric (TTX-030 + Budigalimab + mFOLFOX6)
n=41 Participants
Participants in Cohort 3B were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
|
Cohort 12 - Gastric (Budigalimab + mFOLFOX6)
n=23 Participants
Participants in Cohort 12 were administered IV budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
|
Cohort 3A - Gastric (TTX-030 + mFOLFOX6)
n=4 Participants
Participants in Cohort 3A were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
|
Cohort 2 - mCRPC (TTX-030 + Budigalimab + Docetaxel)
n=7 Participants
Participants in Safety Lead-in Cohort 2 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab 375mg Q3W plus docetaxel at a dose of 75 mg/m2 Q3W on Day 1 of each 21-day treatment cycle.
|
Cohort 9 - Pancreatic (TTX-030 + Budigalimab + Gemcitabine + Nab-Paclitaxel)
n=27 Participants
Participants in Cohort 9 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
|
Cohort 11 - Pancreatic (TTX-030 + Gemcitabine + Nab-Paclitaxel)
n=17 Participants
Participants in Cohort 11 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
|
Cohort 4 - CRC (TTX-030 + Budigalimab)
n=12 Participants
Participants in Cohort 4 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
|
Cohort 6 - HNSCC (TTX-030 + Budigalimab)
n=5 Participants
Participants in Cohort 6 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
|
Cohort 8 - GEC (TTX-030 + Budigalimab)
n=22 Participants
Participants in Cohort 8 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Disease Control Rate (DCR)
|
1 Participants
|
3 Participants
|
37 Participants
|
22 Participants
|
3 Participants
|
2 Participants
|
22 Participants
|
14 Participants
|
3 Participants
|
1 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1 yearPopulation: Participants with events (PFS) by Investigator
PFS is measured from documentation of progression or death from any cause, whichever occurs first
Outcome measures
| Measure |
Cohort 10 - UCC (TTX-030 + Pembrolizumab)
n=8 Participants
Participants in Cohort 10 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus pembrolizumab at a dose of 200 mg Q3W on Day 1 of each 21-day treatment cycle.
|
Cohort 1 - Safety Lead-in (TTX-030 + Budigalimab + mFOLFOX6)
n=7 Participants
Participants in Cohort 1 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
|
Cohort 3B - Gastric (TTX-030 + Budigalimab + mFOLFOX6)
n=41 Participants
Participants in Cohort 3B were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
|
Cohort 12 - Gastric (Budigalimab + mFOLFOX6)
n=23 Participants
Participants in Cohort 12 were administered IV budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
|
Cohort 3A - Gastric (TTX-030 + mFOLFOX6)
n=4 Participants
Participants in Cohort 3A were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
|
Cohort 2 - mCRPC (TTX-030 + Budigalimab + Docetaxel)
n=7 Participants
Participants in Safety Lead-in Cohort 2 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab 375mg Q3W plus docetaxel at a dose of 75 mg/m2 Q3W on Day 1 of each 21-day treatment cycle.
|
Cohort 9 - Pancreatic (TTX-030 + Budigalimab + Gemcitabine + Nab-Paclitaxel)
n=27 Participants
Participants in Cohort 9 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
|
Cohort 11 - Pancreatic (TTX-030 + Gemcitabine + Nab-Paclitaxel)
n=17 Participants
Participants in Cohort 11 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
|
Cohort 4 - CRC (TTX-030 + Budigalimab)
n=12 Participants
Participants in Cohort 4 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
|
Cohort 6 - HNSCC (TTX-030 + Budigalimab)
n=5 Participants
Participants in Cohort 6 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
|
Cohort 8 - GEC (TTX-030 + Budigalimab)
n=22 Participants
Participants in Cohort 8 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Progression-free Survival (PFS)
Participants censored
|
2 Participants
|
1 Participants
|
12 Participants
|
11 Participants
|
0 Participants
|
4 Participants
|
8 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Progression-free Survival (PFS)
PD
|
6 Participants
|
5 Participants
|
27 Participants
|
9 Participants
|
4 Participants
|
3 Participants
|
14 Participants
|
15 Participants
|
10 Participants
|
3 Participants
|
17 Participants
|
|
Progression-free Survival (PFS)
Death
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1 yearPopulation: Participants with events (death)
OS was defined as the time interval from the first dose of study treatment to death from any cause. Participants who were lost to follow-up or survived until the end of the study were censored at the last date that they were known to be alive. Medians, Q1, and Q3 of OS and the proportion of participants who were alive at 3, 6, 9, and 12 months from Study Day 1 were derived using KM methods.
Outcome measures
| Measure |
Cohort 10 - UCC (TTX-030 + Pembrolizumab)
n=8 Participants
Participants in Cohort 10 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus pembrolizumab at a dose of 200 mg Q3W on Day 1 of each 21-day treatment cycle.
|
Cohort 1 - Safety Lead-in (TTX-030 + Budigalimab + mFOLFOX6)
n=7 Participants
Participants in Cohort 1 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
|
Cohort 3B - Gastric (TTX-030 + Budigalimab + mFOLFOX6)
n=41 Participants
Participants in Cohort 3B were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
|
Cohort 12 - Gastric (Budigalimab + mFOLFOX6)
n=23 Participants
Participants in Cohort 12 were administered IV budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
|
Cohort 3A - Gastric (TTX-030 + mFOLFOX6)
n=4 Participants
Participants in Cohort 3A were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
|
Cohort 2 - mCRPC (TTX-030 + Budigalimab + Docetaxel)
n=7 Participants
Participants in Safety Lead-in Cohort 2 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab 375mg Q3W plus docetaxel at a dose of 75 mg/m2 Q3W on Day 1 of each 21-day treatment cycle.
|
Cohort 9 - Pancreatic (TTX-030 + Budigalimab + Gemcitabine + Nab-Paclitaxel)
n=27 Participants
Participants in Cohort 9 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
|
Cohort 11 - Pancreatic (TTX-030 + Gemcitabine + Nab-Paclitaxel)
n=17 Participants
Participants in Cohort 11 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
|
Cohort 4 - CRC (TTX-030 + Budigalimab)
n=12 Participants
Participants in Cohort 4 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
|
Cohort 6 - HNSCC (TTX-030 + Budigalimab)
n=5 Participants
Participants in Cohort 6 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
|
Cohort 8 - GEC (TTX-030 + Budigalimab)
n=22 Participants
Participants in Cohort 8 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS)
AE
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Overall Survival (OS)
PD
|
1 Participants
|
1 Participants
|
13 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
9 Participants
|
8 Participants
|
6 Participants
|
1 Participants
|
8 Participants
|
|
Overall Survival (OS)
Other
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Overall Survival (OS)
Participants censored
|
7 Participants
|
5 Participants
|
28 Participants
|
16 Participants
|
2 Participants
|
7 Participants
|
16 Participants
|
9 Participants
|
5 Participants
|
3 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Cycles 1-4 (each cycle is 21-28 days)Population: Pharmacokinetic Parameters of Serum TTX-030 by Treatment and Visit at C1D1
Serum concentrations of TTX-030 will be tabulated
Outcome measures
| Measure |
Cohort 10 - UCC (TTX-030 + Pembrolizumab)
Participants in Cohort 10 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus pembrolizumab at a dose of 200 mg Q3W on Day 1 of each 21-day treatment cycle.
|
Cohort 1 - Safety Lead-in (TTX-030 + Budigalimab + mFOLFOX6)
n=49 Participants
Participants in Cohort 1 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
|
Cohort 3B - Gastric (TTX-030 + Budigalimab + mFOLFOX6)
n=6 Participants
Participants in Cohort 3B were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
|
Cohort 12 - Gastric (Budigalimab + mFOLFOX6)
n=7 Participants
Participants in Cohort 12 were administered IV budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
|
Cohort 3A - Gastric (TTX-030 + mFOLFOX6)
n=28 Participants
Participants in Cohort 3A were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
|
Cohort 2 - mCRPC (TTX-030 + Budigalimab + Docetaxel)
n=16 Participants
Participants in Safety Lead-in Cohort 2 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab 375mg Q3W plus docetaxel at a dose of 75 mg/m2 Q3W on Day 1 of each 21-day treatment cycle.
|
Cohort 9 - Pancreatic (TTX-030 + Budigalimab + Gemcitabine + Nab-Paclitaxel)
n=41 Participants
Participants in Cohort 9 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
|
Cohort 11 - Pancreatic (TTX-030 + Gemcitabine + Nab-Paclitaxel)
n=7 Participants
Participants in Cohort 11 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
|
Cohort 4 - CRC (TTX-030 + Budigalimab)
Participants in Cohort 4 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
|
Cohort 6 - HNSCC (TTX-030 + Budigalimab)
Participants in Cohort 6 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
|
Cohort 8 - GEC (TTX-030 + Budigalimab)
Participants in Cohort 8 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK)
|
—
|
503 (ug/mL)
Geometric Coefficient of Variation 39.1
|
449 (ug/mL)
Geometric Coefficient of Variation 24.1
|
814 (ug/mL)
Geometric Coefficient of Variation 26.4
|
511 (ug/mL)
Geometric Coefficient of Variation 28.1
|
458 (ug/mL)
Geometric Coefficient of Variation 15.5
|
601 (ug/mL)
Geometric Coefficient of Variation 41.3
|
679 (ug/mL)
Geometric Coefficient of Variation 31.3
|
—
|
—
|
—
|
Adverse Events
Cohort 1 - Safety Lead-in (TTX-030 + Budigalimab + mFOLFOX6)
Serious events: 4 serious events
Other events: 8 other events
Deaths: 2 deaths
Cohort 3B - Gastric (TTX-030 + Budigalimab + mFOLFOX6)
Serious events: 27 serious events
Other events: 43 other events
Deaths: 13 deaths
Cohort 12 - Gastric (Budigalimab + mFOLFOX6)
Serious events: 16 serious events
Other events: 25 other events
Deaths: 7 deaths
Cohort 3A - Gastric (TTX-030 + mFOLFOX6)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 2 deaths
Cohort 2 - mCRPC (TTX-030 + Budigalimab + Docetaxel)
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 9 - Pancreatic (TTX-030 + Budigalimab + Gemcitabine + Nab-Paclitaxel)
Serious events: 16 serious events
Other events: 28 other events
Deaths: 11 deaths
Cohort 11 - Pancreatic (TTX-030 + Gemcitabine + Nab-Paclitaxel)
Serious events: 8 serious events
Other events: 17 other events
Deaths: 8 deaths
Cohort 4 - CRC (TTX-030 + Budigalimab)
Serious events: 4 serious events
Other events: 14 other events
Deaths: 7 deaths
Cohort 6 - HNSCC (TTX-030 + Budigalimab)
Serious events: 2 serious events
Other events: 1 other events
Deaths: 2 deaths
Cohort 8 - GEC (TTX-030 + Budigalimab)
Serious events: 10 serious events
Other events: 23 other events
Deaths: 10 deaths
Cohort 10 - UCC (TTX-030 + Pembrolizumab)
Serious events: 3 serious events
Other events: 8 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Cohort 1 - Safety Lead-in (TTX-030 + Budigalimab + mFOLFOX6)
n=8 participants at risk
Participants in Cohort 1 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
|
Cohort 3B - Gastric (TTX-030 + Budigalimab + mFOLFOX6)
n=44 participants at risk
Participants in Cohort 3B were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
|
Cohort 12 - Gastric (Budigalimab + mFOLFOX6)
n=25 participants at risk
Participants in Cohort 12 were administered IV budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
|
Cohort 3A - Gastric (TTX-030 + mFOLFOX6)
n=6 participants at risk
Participants in Cohort 3A were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
|
Cohort 2 - mCRPC (TTX-030 + Budigalimab + Docetaxel)
n=7 participants at risk
Participants in Safety Lead-in Cohort 2 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab 375 mg Q3W plus docetaxel at a dose of 75 mg/m2 Q3W on Day 1 of each 21-day treatment cycle.
|
Cohort 9 - Pancreatic (TTX-030 + Budigalimab + Gemcitabine + Nab-Paclitaxel)
n=28 participants at risk
Participants in Cohort 9 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
|
Cohort 11 - Pancreatic (TTX-030 + Gemcitabine + Nab-Paclitaxel)
n=17 participants at risk
Participants in Cohort 11 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
|
Cohort 4 - CRC (TTX-030 + Budigalimab)
n=14 participants at risk
Participants in Cohort 4 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
|
Cohort 6 - HNSCC (TTX-030 + Budigalimab)
n=5 participants at risk
Participants in Cohort 6 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
|
Cohort 8 - GEC (TTX-030 + Budigalimab)
n=23 participants at risk
Participants in Cohort 8 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
|
Cohort 10 - UCC (TTX-030 + Pembrolizumab)
n=8 participants at risk
Participants in Cohort 10 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus pembrolizumab at a dose of 200 mg Q3W on Day 1 of each 21-day treatment cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Skin injury
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
3.6%
1/28 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
2.3%
1/44 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
4.5%
2/44 • Number of events 2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
3.6%
1/28 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
3.6%
1/28 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
5.9%
1/17 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Blood and lymphatic system disorders
Blood loss anemia
|
12.5%
1/8 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
2.3%
1/44 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
2.3%
1/44 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Endocrine disorders
Hypophysitis
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
2.3%
1/44 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
4.3%
1/23 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
2.3%
1/44 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
4.0%
1/25 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
5.9%
1/17 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
4.0%
1/25 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
3.6%
1/28 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
5.9%
1/17 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
8.0%
2/25 • Number of events 2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
2.3%
1/44 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
3.6%
1/28 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
2.3%
1/44 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
7.1%
1/14 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
4.3%
1/23 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
2.3%
1/44 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
2.3%
1/44 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
2.3%
1/44 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
5.9%
1/17 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
4.0%
1/25 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
2.3%
1/44 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
2.3%
1/44 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
3.6%
1/28 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
3.6%
1/28 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
2.3%
1/44 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Gastrointestinal disorders
Oesophageal haemorrhage
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
16.7%
1/6 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Gastrointestinal disorders
Pancreatic pseudocyst haemorrhage
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
3.6%
1/28 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
General disorders
Pyrexia
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
4.5%
2/44 • Number of events 2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
4.0%
1/25 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
General disorders
Fatigue
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
7.1%
2/28 • Number of events 2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
General disorders
Asthenia
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
5.9%
1/17 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
General disorders
Generalised oedema
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
5.9%
1/17 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
2.3%
1/44 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
5.9%
1/17 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
3.6%
1/28 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
3.6%
1/28 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Hepatobiliary disorders
Hepatic ischaemia
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
3.6%
1/28 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Immune system disorders
Drug hypersensitivity
|
12.5%
1/8 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
4.5%
2/44 • Number of events 2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
5.9%
1/17 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
2.3%
1/44 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
4.0%
1/25 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
16.7%
1/6 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
2.3%
1/44 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Infections and infestations
COVID-19
|
12.5%
1/8 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
22.7%
10/44 • Number of events 10 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
28.0%
7/25 • Number of events 7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
16.7%
1/6 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
28.6%
2/7 • Number of events 2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
10.7%
3/28 • Number of events 3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
11.8%
2/17 • Number of events 2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
7.1%
1/14 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
12.5%
1/8 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
16.7%
1/6 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
3.6%
1/28 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
8.7%
2/23 • Number of events 2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Infections and infestations
Sepsis
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
2.3%
1/44 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
5.9%
1/17 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Infections and infestations
Abdominal wall abscess
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
2.3%
1/44 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
3.6%
1/28 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Infections and infestations
Device related infection
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
2.3%
1/44 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
2.3%
1/44 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Infections and infestations
Klebsiella sepsis
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
3.6%
1/28 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
3.6%
1/28 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
12.5%
1/8 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Injury, poisoning and procedural complications
Fall
|
12.5%
1/8 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
4.0%
1/25 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
2.3%
1/44 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
2.3%
1/44 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
14.3%
1/7 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
3.6%
1/28 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
2.3%
1/44 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
5.9%
1/17 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Metabolism and nutrition disorders
Dehydration
|
12.5%
1/8 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
4.3%
1/23 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
2.3%
1/44 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
12.5%
1/8 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Nervous system disorders
Syncope
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
2.3%
1/44 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
7.1%
2/28 • Number of events 2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
20.0%
1/5 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
3.6%
1/28 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Nervous system disorders
Hydrocephalus
|
12.5%
1/8 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Nervous system disorders
Seizure
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
3.6%
1/28 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
3.6%
1/28 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Renal and urinary disorders
Acute kidney injury
|
12.5%
1/8 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
14.3%
1/7 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
3.6%
1/28 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
7.1%
1/14 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
4.3%
1/23 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
12.5%
1/8 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Renal and urinary disorders
Anuria
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
3.6%
1/28 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
2.3%
1/44 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
16.0%
4/25 • Number of events 4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
14.3%
1/7 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
12.5%
1/8 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
2.3%
1/44 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
3.6%
1/28 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
11.8%
2/17 • Number of events 2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
4.3%
1/23 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
5.9%
1/17 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
4.3%
1/23 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
5.9%
1/17 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
3.6%
1/28 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
14.3%
1/7 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
3.6%
1/28 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
2.3%
1/44 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
14.3%
1/7 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
7.1%
2/28 • Number of events 2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
4.0%
1/25 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
4.3%
1/23 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
4.3%
1/23 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
12.5%
1/8 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
12.5%
1/8 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
4.3%
1/23 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
12.5%
1/8 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
7.1%
1/14 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
12.5%
1/8 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Infections and infestations
Tracheitis
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
20.0%
1/5 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
4.3%
1/23 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
4.3%
1/23 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
4.3%
1/23 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
20.0%
1/5 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Nervous system disorders
Bell's palsy
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
4.3%
1/23 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
20.0%
1/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
Other adverse events
| Measure |
Cohort 1 - Safety Lead-in (TTX-030 + Budigalimab + mFOLFOX6)
n=8 participants at risk
Participants in Cohort 1 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
|
Cohort 3B - Gastric (TTX-030 + Budigalimab + mFOLFOX6)
n=44 participants at risk
Participants in Cohort 3B were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
|
Cohort 12 - Gastric (Budigalimab + mFOLFOX6)
n=25 participants at risk
Participants in Cohort 12 were administered IV budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
|
Cohort 3A - Gastric (TTX-030 + mFOLFOX6)
n=6 participants at risk
Participants in Cohort 3A were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
|
Cohort 2 - mCRPC (TTX-030 + Budigalimab + Docetaxel)
n=7 participants at risk
Participants in Safety Lead-in Cohort 2 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab 375 mg Q3W plus docetaxel at a dose of 75 mg/m2 Q3W on Day 1 of each 21-day treatment cycle.
|
Cohort 9 - Pancreatic (TTX-030 + Budigalimab + Gemcitabine + Nab-Paclitaxel)
n=28 participants at risk
Participants in Cohort 9 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
|
Cohort 11 - Pancreatic (TTX-030 + Gemcitabine + Nab-Paclitaxel)
n=17 participants at risk
Participants in Cohort 11 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
|
Cohort 4 - CRC (TTX-030 + Budigalimab)
n=14 participants at risk
Participants in Cohort 4 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
|
Cohort 6 - HNSCC (TTX-030 + Budigalimab)
n=5 participants at risk
Participants in Cohort 6 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
|
Cohort 8 - GEC (TTX-030 + Budigalimab)
n=23 participants at risk
Participants in Cohort 8 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
|
Cohort 10 - UCC (TTX-030 + Pembrolizumab)
n=8 participants at risk
Participants in Cohort 10 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus pembrolizumab at a dose of 200 mg Q3W on Day 1 of each 21-day treatment cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
25.0%
11/44 • Number of events 11 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
4.0%
1/25 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
33.3%
2/6 • Number of events 2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
17.9%
5/28 • Number of events 5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
17.6%
3/17 • Number of events 3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
21.4%
3/14 • Number of events 3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
30.4%
7/23 • Number of events 7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
20.5%
9/44 • Number of events 9 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
20.0%
5/25 • Number of events 5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
25.0%
7/28 • Number of events 7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
23.5%
4/17 • Number of events 4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
12.5%
1/8 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
11.4%
5/44 • Number of events 5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
4.0%
1/25 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
33.3%
2/6 • Number of events 2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
71.4%
5/7 • Number of events 5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
42.9%
12/28 • Number of events 12 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
35.3%
6/17 • Number of events 6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Blood and lymphatic system disorders
Anemia
|
25.0%
2/8 • Number of events 2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
20.5%
9/44 • Number of events 9 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
28.0%
7/25 • Number of events 7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
33.3%
2/6 • Number of events 2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
28.6%
2/7 • Number of events 2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
53.6%
15/28 • Number of events 15 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
41.2%
7/17 • Number of events 7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
20.0%
1/5 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
17.4%
4/23 • Number of events 4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
12.5%
1/8 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
18.2%
8/44 • Number of events 8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
20.0%
5/25 • Number of events 5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
32.1%
9/28 • Number of events 9 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
23.5%
4/17 • Number of events 4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
40.9%
18/44 • Number of events 18 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
20.0%
5/25 • Number of events 5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
50.0%
3/6 • Number of events 3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
14.3%
1/7 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
21.4%
6/28 • Number of events 6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
35.3%
6/17 • Number of events 6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
14.3%
2/14 • Number of events 2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
30.4%
7/23 • Number of events 7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
12.5%
1/8 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
General disorders
Cough
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
15.9%
7/44 • Number of events 7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
12.0%
3/25 • Number of events 3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
3.6%
1/28 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
11.8%
2/17 • Number of events 2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
7.1%
1/14 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
26.1%
6/23 • Number of events 6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
12.5%
1/8 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
General disorders
COVID-19
|
12.5%
1/8 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
22.7%
10/44 • Number of events 10 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
28.0%
7/25 • Number of events 7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
16.7%
1/6 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
28.6%
2/7 • Number of events 2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
10.7%
3/28 • Number of events 3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
11.8%
2/17 • Number of events 2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.5%
1/8 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
43.2%
19/44 • Number of events 19 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
32.0%
8/25 • Number of events 8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
50.0%
3/6 • Number of events 3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
35.7%
10/28 • Number of events 10 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
41.2%
7/17 • Number of events 7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
43.5%
10/23 • Number of events 10 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
1/8 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
43.2%
19/44 • Number of events 19 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
24.0%
6/25 • Number of events 6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
33.3%
2/6 • Number of events 2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
28.6%
2/7 • Number of events 2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
35.7%
10/28 • Number of events 10 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
29.4%
5/17 • Number of events 5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Blood and lymphatic system disorders
Edema peripheral
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
6.8%
3/44 • Number of events 3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
16.7%
1/6 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
28.6%
2/7 • Number of events 2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
28.6%
8/28 • Number of events 8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
23.5%
4/17 • Number of events 4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
26.1%
6/23 • Number of events 6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
25.0%
2/8 • Number of events 2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
General disorders
Fatigue
|
25.0%
2/8 • Number of events 2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
38.6%
17/44 • Number of events 17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
24.0%
6/25 • Number of events 6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
33.3%
2/6 • Number of events 2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
100.0%
7/7 • Number of events 7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
64.3%
18/28 • Number of events 18 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
64.7%
11/17 • Number of events 11 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
14.3%
2/14 • Number of events 2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
47.8%
11/23 • Number of events 11 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
63.6%
28/44 • Number of events 28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
60.0%
15/25 • Number of events 15 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
66.7%
4/6 • Number of events 4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
42.9%
3/7 • Number of events 3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
57.1%
16/28 • Number of events 16 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
52.9%
9/17 • Number of events 9 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
21.4%
3/14 • Number of events 3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
30.4%
7/23 • Number of events 7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
12.5%
1/8 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Nervous system disorders
Neuropathy peripheral
|
12.5%
1/8 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
36.4%
16/44 • Number of events 16 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
24.0%
6/25 • Number of events 6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
33.3%
2/6 • Number of events 2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
28.6%
2/7 • Number of events 2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
32.1%
9/28 • Number of events 9 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
23.5%
4/17 • Number of events 4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Investigations
Neutrophil count decreased
|
37.5%
3/8 • Number of events 3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
61.4%
27/44 • Number of events 27 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
68.0%
17/25 • Number of events 17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
16.7%
1/6 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
57.1%
4/7 • Number of events 4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
42.9%
12/28 • Number of events 12 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
58.8%
10/17 • Number of events 10 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
12.5%
1/8 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
29.5%
13/44 • Number of events 13 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
32.0%
8/25 • Number of events 8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
16.7%
1/6 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
42.9%
3/7 • Number of events 3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
14.3%
4/28 • Number of events 4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
23.5%
4/17 • Number of events 4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Investigations
Platelet count decreased
|
50.0%
4/8 • Number of events 4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
18.2%
8/44 • Number of events 8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
12.0%
3/25 • Number of events 3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
16.7%
1/6 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
28.6%
8/28 • Number of events 8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
35.3%
6/17 • Number of events 6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
25.0%
11/44 • Number of events 11 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
20.0%
5/25 • Number of events 5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
28.6%
2/7 • Number of events 2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
7.1%
2/28 • Number of events 2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
17.6%
3/17 • Number of events 3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
General disorders
Pyrexia
|
25.0%
2/8 • Number of events 2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
29.5%
13/44 • Number of events 13 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
12.0%
3/25 • Number of events 3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
35.7%
10/28 • Number of events 10 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
23.5%
4/17 • Number of events 4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/23 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
35.7%
5/14 • Number of events 5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
8.7%
2/23 • Number of events 2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
12.5%
1/8 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
26.1%
6/23 • Number of events 6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
7.1%
1/14 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
17.4%
4/23 • Number of events 4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
12.5%
1/8 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
21.4%
3/14 • Number of events 3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
4.3%
1/23 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
12.5%
1/8 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/44 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/25 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/28 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/17 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
14.3%
2/14 • Number of events 2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
13.0%
3/23 • Number of events 3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place