Trial Outcomes & Findings for A Study of GFH018 in Patients With Advanced Solid Tumors (NCT NCT05051241)
NCT ID: NCT05051241
Last Updated: 2024-03-01
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
50 participants
Primary outcome timeframe
31 days after the first dose
Results posted on
2024-03-01
Participant Flow
A total of 50 participants who met all inclusion and no exclusion criteria were enrolled at 5 centers in China. A total of 47 participants started the Dose Escalation phase and three participants in the Dose Expansion phase.
The Dose Escalation was intended to identify the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of GFH018 with at least 3 participants evaluable for assessment of dose-limiting toxicity per dose level. Since the MTD was not reached, 85 mg BID, 14d-on/14d-off was chosen for evaluation in the Dose Expansion phase.
Participant milestones
| Measure |
Dose Escalation: Cohort 1 5 mg BID, 14d-on/14d-off
Participants in Cohort 1 received GFH018 5 mg BID, 14d-on/14d-off orally
|
Dose Escalation: Cohort 2 10 mg BID, 14d-on/14d-off
Participants in Cohort 2 received GFH018 10 mg BID, 14d-on/14d-off
|
Dose Escalation: Cohort 3 20 mg BID, 14d-on/14d-off
Participants in Cohort 3 received GFH018 20 mg BID, 14d-on/14d-off
|
Dose Escalation: Cohort 4 30 mg BID, 14d-on/14d-off
Participants in Cohort 4 received GFH018 30 mg BID, 14d-on/14d-off orally
|
Dose Escalation: Cohort 5 40 mg BID, 14d-on/14d-off
Participants in Cohort 5 received GFH018 40 mg BID, 14d-on/14d-off orally
|
Dose Escalation: Cohort 6 50 mg BID, 14d-on/14d-off
Participants in Cohort 6 received GFH018 50 mg BID, 14d-on/14d-off orally
|
Dose Escalation: Cohort 7 65 mg BID, 14d-on/14d-off
Participants in Cohort 7 received GFH018 65 mg BID, 14d-on/14d-off orally
|
Dose Escalation: Cohort 8 85 mg BID, 14d-on/14d-off
Participants in Cohort 8 received GFH018 85 mg BID, 14d-on/14d-off orally
|
Dose Escalation: Cohort 9 85 mg BID, 7d-on/7d-off
Participants in Cohort 9 received GFH018 85 mg BID, 7d-on/7d-off orally
|
Dose Expansion: Cohort 10 85 mg BID, 14d-on/14d-off
Participants in Cohort 10 received GFH018 85 mg BID, 14d-on/14d-off orally
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation
STARTED
|
4
|
3
|
4
|
7
|
4
|
4
|
6
|
9
|
6
|
0
|
|
Dose Escalation
COMPLETED
|
4
|
3
|
4
|
7
|
4
|
4
|
6
|
9
|
6
|
0
|
|
Dose Escalation
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Expansion
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
|
Dose Expansion
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
|
Dose Expansion
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of GFH018 in Patients With Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
Dose Escalation Cohort 1 5 mg BID, 14d-on/14d-off
n=4 Participants
Participants in Cohort 1 received GFH018 5 mg BID, 14d-on/14d-off orally
|
Dose Escalation: Cohort 2 10 mg BID, 14d-on/14d-off
n=3 Participants
Participants in Cohort 2 received GFH018 10 mg BID, 14d-on/14d-off
|
Dose Escalation: Cohort 3 20 mg BID, 14d-on/14d-off
n=4 Participants
Participants in Cohort 3 received GFH018 20 mg BID, 14d-on/14d-off
|
Dose Escalation: Cohort 4 30 mg BID, 14d-on/14d-off
n=7 Participants
Participants in Cohort 4 received GFH018 30 mg BID, 14d-on/14d-off
|
Dose Escalation: Cohort 5 40 mg BID, 14d-on/14d-off
n=4 Participants
Participants in Cohort 5 received GFH018 40 mg BID, 14d-on/14d-off
|
Dose Escalation: Cohort 6 50 mg BID, 14d-on/14d-off
n=4 Participants
Participants in Cohort 6 received GFH018 50 mg BID, 14d-on/14d-off
|
Dose Escalation: Cohort 7 65 mg BID, 14d-on/14d-off
n=6 Participants
Participants in Cohort 7 received GFH018 65 mg BID, 14d-on/14d-off
|
Dose Escalation: Cohort 8 85 mg BID, 14d-on/14d-off
n=9 Participants
Participants in Cohort 8 received GFH018 85 mg BID, 14d-on/14d-off
|
Dose Escalation: Cohort 9 85 mg BID, 7d-on/7d-off
n=6 Participants
Participants in Cohort 9 received GFH018 85 mg BID, 7d-on/7d-off
|
Dose Expansion: Cohort 10 85 mg BID, 14d-on/14d-off
n=3 Participants
Participants in Cohort 10 received GFH018 85 mg BID, 14d-on/14d-off
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
44 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
|
Age, Continuous
|
53.5 years
n=5 Participants
|
39 years
n=7 Participants
|
50.5 years
n=5 Participants
|
51 years
n=4 Participants
|
51.5 years
n=21 Participants
|
55 years
n=8 Participants
|
56.5 years
n=8 Participants
|
52 years
n=24 Participants
|
52.5 years
n=42 Participants
|
49 years
n=42 Participants
|
52.5 years
n=42 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
27 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
23 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
9 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
50 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Region of Enrollment
China
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
7 participants
n=4 Participants
|
4 participants
n=21 Participants
|
4 participants
n=8 Participants
|
6 participants
n=8 Participants
|
9 participants
n=24 Participants
|
6 participants
n=42 Participants
|
3 participants
n=42 Participants
|
50 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: 31 days after the first dosePopulation: Participants enrolled in the expansion part were NOT included in analyzing the incidence of DLT. So the analyzed number of cohort 10 was 0.
Outcome measures
| Measure |
Dose Escalation: Cohort 1 5 mg BID, 14d-on/14d-off
n=4 Participants
Participants in Cohort 1 received GFH018 5 mg BID, 14d-on/14d-off orally
|
Dose Escalation: Cohort 2 10 mg BID, 14d-on/14d-off
n=3 Participants
Participants in Cohort 2 received GFH018 10 mg BID, 14d-on/14d-off orally
|
Dose Escalation: Cohort 3 20 mg BID, 14d-on/14d-off
n=4 Participants
Participants in Cohort 3 received GFH018 20 mg BID, 14d-on/14d-off orally
|
Dose Escalation: Cohort 4 30 mg BID, 14d-on/14d-off
n=7 Participants
Participants in Cohort 4 received GFH018 30 mg BID, 14d-on/14d-off orally
|
Dose Escalation: Cohort 5 40 mg BID, 14d-on/14d-off
n=4 Participants
Participants in Cohort 5 received GFH018 40 mg BID, 14d-on/14d-off orally
|
Dose Escalation: Cohort 6 50 mg BID, 14d-on/14d-off
n=4 Participants
Participants in Cohort 6 received GFH018 50 mg BID, 14d-on/14d-off orally
|
Dose Escalation: Cohort 7 65 mg BID, 14d-on/14d-off
n=6 Participants
Participants in Cohort 7 received GFH018 65 mg BID, 14d-on/14d-off orally
|
Dose Escalation: Cohort 8 85 mg BID, 14d-on/14d-off
n=9 Participants
Participants in Cohort 8 received GFH018 85 mg BID, 14d-on/14d-off orally
|
Dose Escalation: Cohort 9 85 mg BID, 7d-on/7d-off
n=6 Participants
Participants in Cohort 9 received GFH018 85 mg BID, 7d-on/7d-off orally
|
Dose Expansion: Cohort 10 85 mg BID, 14d-on/14d-off
Participants in Cohort 10 received GFH018 85 mg BID, 14d-on/14d-off orally
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Incidence of Dose-limiting Toxicity (DLT) Events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Dose Escalation: Cohort 1 5 mg BID, 14d-on/14d-off
Serious events: 1 serious events
Other events: 4 other events
Deaths: 1 deaths
Dose Escalation: Cohort 2 10 mg BID, 14d-on/14d-off
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Escalation: Cohort 3 20 mg BID, 14d-on/14d-off
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Dose Escalation: Cohort 4 30 mg BID, 14d-on/14d-off
Serious events: 5 serious events
Other events: 7 other events
Deaths: 2 deaths
Dose Escalation: Cohort 5 40 mg BID, 14d-on/14d-off
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Dose Escalation: Cohort 6 50 mg BID, 14d-on/14d-off
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Dose Escalation: Cohort 7 65 mg BID, 14d-on/14d-off
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Dose Escalation: Cohort 8 85 mg BID, 14d-on/14d-off
Serious events: 2 serious events
Other events: 8 other events
Deaths: 2 deaths
Dose Escalation: Cohort 9 85 mg BID, 7d-on/7d-off
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Dose Expansion: Cohort 10 85 mg BID, 14d-on/14d-off
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose Escalation: Cohort 1 5 mg BID, 14d-on/14d-off
n=4 participants at risk
Participants in Cohort 1 received GFH018 5 mg BID, 14d-on/14d-off orally
|
Dose Escalation: Cohort 2 10 mg BID, 14d-on/14d-off
n=3 participants at risk
Participants in Cohort 2 received GFH018 10 mg BID, 14d-on/14d-off orally
|
Dose Escalation: Cohort 3 20 mg BID, 14d-on/14d-off
n=4 participants at risk
Participants in Cohort 3 received GFH018 10 mg BID, 14d-on/14d-off orally
|
Dose Escalation: Cohort 4 30 mg BID, 14d-on/14d-off
n=7 participants at risk
Participants in Cohort 4 received GFH018 30 mg BID, 14d-on/14d-off orally
|
Dose Escalation: Cohort 5 40 mg BID, 14d-on/14d-off
n=4 participants at risk
Participants in Cohort 5 received GFH018 40 mg BID, 14d-on/14d-off orally
|
Dose Escalation: Cohort 6 50 mg BID, 14d-on/14d-off
n=4 participants at risk
Participants in Cohort 6 received GFH018 50 mg BID, 14d-on/14d-off orally
|
Dose Escalation: Cohort 7 65 mg BID, 14d-on/14d-off
n=6 participants at risk
Participants in Cohort 7 received GFH01865 mg BID, 14d-on/14d-off orally
|
Dose Escalation: Cohort 8 85 mg BID, 14d-on/14d-off
n=9 participants at risk
Participants in Cohort 8 received GFH018 85 mg BID, 14d-on/14d-off orally
|
Dose Escalation: Cohort 9 85 mg BID, 7d-on/7d-off
n=6 participants at risk
Participants in Cohort 9 received GFH018 85 mg BID, 7d-on/17d-off orally
|
Dose Expansion: Cohort 10 85 mg BID, 14d-on/14d-off
n=3 participants at risk
Participants in Cohort 10 received GFH018 85 mg BID, 14d-on/14d-off orally
|
|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Sudden death
|
25.0%
1/4 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
25.0%
1/4 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasma progression
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
33.3%
1/3 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
14.3%
1/7 • Number of events 2 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
14.3%
1/7 • Number of events 2 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
|
General disorders
Oedema peripheral
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
|
Renal and urinary disorders
Proteinuira
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
Other adverse events
| Measure |
Dose Escalation: Cohort 1 5 mg BID, 14d-on/14d-off
n=4 participants at risk
Participants in Cohort 1 received GFH018 5 mg BID, 14d-on/14d-off orally
|
Dose Escalation: Cohort 2 10 mg BID, 14d-on/14d-off
n=3 participants at risk
Participants in Cohort 2 received GFH018 10 mg BID, 14d-on/14d-off orally
|
Dose Escalation: Cohort 3 20 mg BID, 14d-on/14d-off
n=4 participants at risk
Participants in Cohort 3 received GFH018 10 mg BID, 14d-on/14d-off orally
|
Dose Escalation: Cohort 4 30 mg BID, 14d-on/14d-off
n=7 participants at risk
Participants in Cohort 4 received GFH018 30 mg BID, 14d-on/14d-off orally
|
Dose Escalation: Cohort 5 40 mg BID, 14d-on/14d-off
n=4 participants at risk
Participants in Cohort 5 received GFH018 40 mg BID, 14d-on/14d-off orally
|
Dose Escalation: Cohort 6 50 mg BID, 14d-on/14d-off
n=4 participants at risk
Participants in Cohort 6 received GFH018 50 mg BID, 14d-on/14d-off orally
|
Dose Escalation: Cohort 7 65 mg BID, 14d-on/14d-off
n=6 participants at risk
Participants in Cohort 7 received GFH01865 mg BID, 14d-on/14d-off orally
|
Dose Escalation: Cohort 8 85 mg BID, 14d-on/14d-off
n=9 participants at risk
Participants in Cohort 8 received GFH018 85 mg BID, 14d-on/14d-off orally
|
Dose Escalation: Cohort 9 85 mg BID, 7d-on/7d-off
n=6 participants at risk
Participants in Cohort 9 received GFH018 85 mg BID, 7d-on/17d-off orally
|
Dose Expansion: Cohort 10 85 mg BID, 14d-on/14d-off
n=3 participants at risk
Participants in Cohort 10 received GFH018 85 mg BID, 14d-on/14d-off orally
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Investigations
AST increased
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
28.6%
2/7 • Number of events 2 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
25.0%
1/4 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
33.3%
2/6 • Number of events 2 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
33.3%
3/9 • Number of events 3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
33.3%
1/3 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
50.0%
2/4 • Number of events 2 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
42.9%
3/7 • Number of events 3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
33.3%
1/3 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
33.3%
2/6 • Number of events 2 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
33.3%
3/9 • Number of events 3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
25.0%
1/4 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
22.2%
2/9 • Number of events 2 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
33.3%
2/6 • Number of events 2 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
|
Investigations
ALT increased
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
33.3%
1/3 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
28.6%
2/7 • Number of events 2 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
25.0%
1/4 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
33.3%
1/3 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
|
Investigations
Urine protein present
|
25.0%
1/4 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
33.3%
1/3 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
25.0%
1/4 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
25.0%
1/4 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
|
Investigations
GGT increased
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
66.7%
2/3 • Number of events 2 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
25.0%
1/4 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
22.2%
2/9 • Number of events 2 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
|
Investigations
ALP increased
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
33.3%
1/3 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
25.0%
1/4 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
25.0%
1/4 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
|
Investigations
LDH increased
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
33.3%
1/3 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
25.0%
1/4 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
33.3%
1/3 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
25.0%
1/4 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
33.3%
2/6 • Number of events 2 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
1/4 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
22.2%
2/9 • Number of events 2 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
25.0%
1/4 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
33.3%
1/3 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
22.2%
2/9 • Number of events 2 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
|
Investigations
Electrocardiogram T wave abnormal
|
75.0%
3/4 • Number of events 3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
|
Investigations
Blood glucose increased
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
33.3%
1/3 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
25.0%
1/4 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
|
Investigations
Sinus tachycardia
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
25.0%
1/4 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
33.3%
2/6 • Number of events 2 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
|
General disorders
Peripheral edema
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
25.0%
1/4 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
25.0%
1/4 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
|
Investigations
Amylase increased
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
25.0%
1/4 • Number of events 1 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/4 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 30 days after the last dose of study drug, up to 1 years.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee After the completion of the research, researchers can collaborate with the sponsoring party for publication. Researchers must commit not to submit any part of the data from this study for publication without prior approval from the sponsoring party.
- Publication restrictions are in place
Restriction type: OTHER