Trial Outcomes & Findings for A Phase I/II Study of ASTX660 in Patients With Relapsed or Refractory T-cell Lymphoma (NCT NCT04362007)
NCT ID: NCT04362007
Last Updated: 2026-02-25
Results Overview
Dose-limiting toxicities were defined as AEs occurring during this period that meet any of the following criteria, were not related to the primary disease, complication(s), or concomitant medication(s), and has a reasonable relationship with ASTX660. The Common Terminology Criteria for Adverse Events Version 4.03 (CTCAE v4.03) was used to determine severity. 1. Grade 4 thrombocytopenia, Grade 3 or higher clinically significant bleeding, or anemia requiring a new erythrocyte transfusion 2. Febrile neutropenia that does not resolve within 3 days or Grade 4 neutropenia that lasts for more than 7 days under appropriate treatment 3. Liver-associated abnormalities 4. Excepting the above AEs, any other Grade 3 or higher nonhematologic or Grade 4 hematologic toxicity except Grade 3 nausea, vomiting, or diarrhea lasting less than 48 hours
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
8 participants
Primary outcome timeframe
28 days (Day1 to Day29)
Results posted on
2026-02-25
Participant Flow
Participant milestones
| Measure |
Cohort 2
ASTX660 150mg was orally administered once a day for 7 consecutive days every other week of each 28-day cycle (ie, \[7 days on/ 7 days off\] ×2; daily dosing on Days 1-7 and 15-21).
|
Cohort 1
ASTX660 120mg was orally administered once a day for 7 consecutive days every other week of each 28-day cycle (ie, \[7 days on/ 7 days off\] ×2; daily dosing on Days 1-7 and 15-21).
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
7
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
7
|
Reasons for withdrawal
| Measure |
Cohort 2
ASTX660 150mg was orally administered once a day for 7 consecutive days every other week of each 28-day cycle (ie, \[7 days on/ 7 days off\] ×2; daily dosing on Days 1-7 and 15-21).
|
Cohort 1
ASTX660 120mg was orally administered once a day for 7 consecutive days every other week of each 28-day cycle (ie, \[7 days on/ 7 days off\] ×2; daily dosing on Days 1-7 and 15-21).
|
|---|---|---|
|
Overall Study
Progressive Disease or Disease Relapse
|
1
|
4
|
|
Overall Study
Adverse Event
|
0
|
2
|
|
Overall Study
Study Terminated by Sponsor
|
0
|
1
|
Baseline Characteristics
A Phase I/II Study of ASTX660 in Patients With Relapsed or Refractory T-cell Lymphoma
Baseline characteristics by cohort
| Measure |
Cohort 1
n=7 Participants
ASTX660 120mg was orally administered once a day for 7 consecutive days every other week of each 28-day cycle (ie, \[7 days on/ 7 days off\] ×2; daily dosing on Days 1-7 and 15-21).
|
Cohort 2
n=1 Participants
ASTX660 150mg was orally administered once a day for 7 consecutive days every other week of each 28-day cycle (ie, \[7 days on/ 7 days off\] ×2; daily dosing on Days 1-7 and 15-21).
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.9 years
STANDARD_DEVIATION 9.9 • n=24 Participants
|
77 years
STANDARD_DEVIATION 0 • n=20 Participants
|
69.0 years
STANDARD_DEVIATION 9.8 • n=40 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=24 Participants
|
1 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=24 Participants
|
1 Participants
n=20 Participants
|
8 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Region of Enrollment
Japan
|
7 participants
n=24 Participants
|
1 participants
n=20 Participants
|
8 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 28 days (Day1 to Day29)Population: The DLT analysis population include all subjects who received at least 1 dose of IMP and have available data necessary for DLT assessment during the DLT assessment period.
Dose-limiting toxicities were defined as AEs occurring during this period that meet any of the following criteria, were not related to the primary disease, complication(s), or concomitant medication(s), and has a reasonable relationship with ASTX660. The Common Terminology Criteria for Adverse Events Version 4.03 (CTCAE v4.03) was used to determine severity. 1. Grade 4 thrombocytopenia, Grade 3 or higher clinically significant bleeding, or anemia requiring a new erythrocyte transfusion 2. Febrile neutropenia that does not resolve within 3 days or Grade 4 neutropenia that lasts for more than 7 days under appropriate treatment 3. Liver-associated abnormalities 4. Excepting the above AEs, any other Grade 3 or higher nonhematologic or Grade 4 hematologic toxicity except Grade 3 nausea, vomiting, or diarrhea lasting less than 48 hours
Outcome measures
| Measure |
Cohort 1
n=6 Participants
ASTX660 120mg was orally administered once a day for 7 consecutive days every other week of each 28-day cycle (ie, \[7 days on/ 7 days off\] ×2; daily dosing on Days 1-7 and 15-21).
|
Cohort 2
ASTX660 150mg was orally administered once a day for 7 consecutive days every other week of each 28-day cycle (ie, \[7 days on/ 7 days off\] ×2; daily dosing on Days 1-7 and 15-21).
|
|---|---|---|
|
Safety (Phase 1 Dose-escalation Part) - Number of Subjects With Dose-limiting Toxicities (DLTs), AEs, Abnormal Clinical Laboratory Values or Physical Exam Results
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Day1: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24hours post-dose, Day7: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24, 48, 72 hours post-dosePopulation: PK analysis population included subjects who received at least 1 dose of IMP and had available ASTX660 concentration measurement data for at least 1 time point.
Assessment of pharmacokinetic parameter area under the concentration-time curve (AUC).
Outcome measures
| Measure |
Cohort 1
n=7 Participants
ASTX660 120mg was orally administered once a day for 7 consecutive days every other week of each 28-day cycle (ie, \[7 days on/ 7 days off\] ×2; daily dosing on Days 1-7 and 15-21).
|
Cohort 2
n=1 Participants
ASTX660 150mg was orally administered once a day for 7 consecutive days every other week of each 28-day cycle (ie, \[7 days on/ 7 days off\] ×2; daily dosing on Days 1-7 and 15-21).
|
|---|---|---|
|
Pharmacokinetic Outcome of Concentration-time Curve (AUC)
Day 1
|
1280 ng∙h/mL
Standard Deviation 915
|
2020 ng∙h/mL
|
|
Pharmacokinetic Outcome of Concentration-time Curve (AUC)
Day 7
|
2410 ng∙h/mL
Standard Deviation 1410
|
—
|
SECONDARY outcome
Timeframe: Day1: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24hours post-dose, Day7: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24, 48, 72 hours post-dosePopulation: PK analysis population included subjects who received at least 1 dose of IMP and had available ASTX660 concentration measurement data for at least 1 time point.
Assessment of pharmacokinetic parameter maximum concentration (Cmax).
Outcome measures
| Measure |
Cohort 1
n=7 Participants
ASTX660 120mg was orally administered once a day for 7 consecutive days every other week of each 28-day cycle (ie, \[7 days on/ 7 days off\] ×2; daily dosing on Days 1-7 and 15-21).
|
Cohort 2
n=1 Participants
ASTX660 150mg was orally administered once a day for 7 consecutive days every other week of each 28-day cycle (ie, \[7 days on/ 7 days off\] ×2; daily dosing on Days 1-7 and 15-21).
|
|---|---|---|
|
Pharmacokinetic Outcome of Maximum Concentration (Cmax)
Day 1
|
249 ng/mL
Standard Deviation 135
|
405 ng/mL
|
|
Pharmacokinetic Outcome of Maximum Concentration (Cmax)
Day 7
|
380 ng/mL
Standard Deviation 180
|
—
|
SECONDARY outcome
Timeframe: Day1: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24hours post-dose, Day7: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24, 48, 72 hours post-dosePopulation: PK analysis population included subjects who received at least 1 dose of IMP and had available ASTX660 concentration measurement data for at least 1 time point.
Assessment of pharmacokinetic parameter time to maximum concentration (Tmax).
Outcome measures
| Measure |
Cohort 1
n=7 Participants
ASTX660 120mg was orally administered once a day for 7 consecutive days every other week of each 28-day cycle (ie, \[7 days on/ 7 days off\] ×2; daily dosing on Days 1-7 and 15-21).
|
Cohort 2
n=1 Participants
ASTX660 150mg was orally administered once a day for 7 consecutive days every other week of each 28-day cycle (ie, \[7 days on/ 7 days off\] ×2; daily dosing on Days 1-7 and 15-21).
|
|---|---|---|
|
Pharmacokinetic Outcome of Time to Maximum Concentration (Tmax)
Day 1
|
0.98 h
Interval 0.5 to 3.0
|
0.48 h
Interval 0.48 to 0.48
|
|
Pharmacokinetic Outcome of Time to Maximum Concentration (Tmax)
Day 7
|
0.94 h
Interval 0.42 to 2.98
|
—
|
SECONDARY outcome
Timeframe: Day1: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24hours post-dose, Day7: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24, 48, 72 hours post-dosePopulation: PK analysis population included subjects who received at least 1 dose of IMP and had available ASTX660 concentration measurement data for at least 1 time point.
Assessment of pharmacokinetic parameter elimination half life (t½).
Outcome measures
| Measure |
Cohort 1
n=7 Participants
ASTX660 120mg was orally administered once a day for 7 consecutive days every other week of each 28-day cycle (ie, \[7 days on/ 7 days off\] ×2; daily dosing on Days 1-7 and 15-21).
|
Cohort 2
n=1 Participants
ASTX660 150mg was orally administered once a day for 7 consecutive days every other week of each 28-day cycle (ie, \[7 days on/ 7 days off\] ×2; daily dosing on Days 1-7 and 15-21).
|
|---|---|---|
|
Pharmacokinetic Outcome of Elimination Half Life (t½)
Day 1
|
9.7 h
Standard Deviation 1.2
|
NA h
For 1 subject in cohort 2, all plasma concentrations and all PK parameters on Cycle 1 Day 7 were excluded from the calculation of descriptive statistics because the subject was administered an unplanned dose (210 mg) on Cycle 1 Day 2, which might affect the assessment of ASTX660 PK results for the planned dose (150 mg) on Cycle 1 Day 7
|
|
Pharmacokinetic Outcome of Elimination Half Life (t½)
Day 7
|
35.3 h
Standard Deviation 5.5
|
—
|
SECONDARY outcome
Timeframe: Day1: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24hours post-dose, Day7: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24, 48, 72 hours post-dosePopulation: PK analysis population included subjects who received at least 1 dose of IMP and had available ASTX660 concentration measurement data for at least 1 time point.
Assessment of pharmacokinetic parameter clearance of drug from plasma.
Outcome measures
| Measure |
Cohort 1
n=7 Participants
ASTX660 120mg was orally administered once a day for 7 consecutive days every other week of each 28-day cycle (ie, \[7 days on/ 7 days off\] ×2; daily dosing on Days 1-7 and 15-21).
|
Cohort 2
n=1 Participants
ASTX660 150mg was orally administered once a day for 7 consecutive days every other week of each 28-day cycle (ie, \[7 days on/ 7 days off\] ×2; daily dosing on Days 1-7 and 15-21).
|
|---|---|---|
|
Pharmacokinetic Outcome of Clearance of Drug From Plasma
Day 1
|
113 L/h
Standard Deviation 62.0
|
NA L/h
For 1 subject in cohort 2, all plasma concentrations and all PK parameters on Cycle 1 Day 7 were excluded from the calculation of descriptive statistics because the subject was administered an unplanned dose (210 mg) on Cycle 1 Day 2, which might affect the assessment of ASTX660 PK results for the planned dose (150 mg) on Cycle 1 Day 7
|
|
Pharmacokinetic Outcome of Clearance of Drug From Plasma
Day 7
|
64.6 L/h
Standard Deviation 34.0
|
—
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1
n=7 participants at risk
ASTX660 120mg was orally administered once a day for 7 consecutive days every other week of each 28-day cycle (ie, \[7 days on/ 7 days off\] ×2; daily dosing on Days 1-7 and 15-21).
|
Cohort 2
n=1 participants at risk
ASTX660 150mg was orally administered once a day for 7 consecutive days every other week of each 28-day cycle (ie, \[7 days on/ 7 days off\] ×2; daily dosing on Days 1-7 and 15-21).
|
|---|---|---|
|
Infections and infestations
Oral candidiasis
|
14.3%
1/7 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
0.00%
0/1 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
|
Infections and infestations
Otitis externa
|
14.3%
1/7 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
0.00%
0/1 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
14.3%
1/7 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
0.00%
0/1 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
14.3%
1/7 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
0.00%
0/1 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
14.3%
1/7 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
0.00%
0/1 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
|
Investigations
Alanine aminotransferase increased
|
14.3%
1/7 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
0.00%
0/1 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
|
Investigations
Amylase increased
|
42.9%
3/7 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
0.00%
0/1 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
14.3%
1/7 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
0.00%
0/1 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
14.3%
1/7 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
0.00%
0/1 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
|
Investigations
Lipase increased
|
28.6%
2/7 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
0.00%
0/1 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
14.3%
1/7 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
0.00%
0/1 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
14.3%
1/7 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
0.00%
0/1 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
1/7 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
0.00%
0/1 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
|
Musculoskeletal and connective tissue disorders
Fracture pain
|
14.3%
1/7 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
0.00%
0/1 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/7 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
100.0%
1/1 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal pain
|
14.3%
1/7 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
0.00%
0/1 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
14.3%
1/7 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
0.00%
0/1 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
14.3%
1/7 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
0.00%
0/1 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
1/7 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
0.00%
0/1 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
1/7 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
0.00%
0/1 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
|
Vascular disorders
Varicose vein
|
14.3%
1/7 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
0.00%
0/1 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
14.3%
1/7 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
0.00%
0/1 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
42.9%
3/7 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
0.00%
0/1 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
14.3%
1/7 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
0.00%
0/1 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
14.3%
1/7 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
0.00%
0/1 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
|
Gastrointestinal disorders
Constipation
|
14.3%
1/7 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
0.00%
0/1 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
14.3%
1/7 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
0.00%
0/1 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
14.3%
1/7 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
0.00%
0/1 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
|
Infections and infestations
Conjunctivitis
|
28.6%
2/7 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
0.00%
0/1 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
|
Infections and infestations
COVID-19
|
14.3%
1/7 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
0.00%
0/1 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
|
Infections and infestations
Gingivitis
|
14.3%
1/7 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
|
0.00%
0/1 • Approximately 52.6 months
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.
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Additional Information
Director of Clinical Trials
Otsuka Pharmaceutical Co., Ltd.
Phone: +81-3-6361-7366
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place