Trial Outcomes & Findings for DT-9081 Study in Participants With Advanced, Recurrent or Metastatic Solid Tumours (NCT NCT05582850)
NCT ID: NCT05582850
Last Updated: 2026-05-12
Results Overview
Number of participants with dose-limiting toxicities (DLTs).
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
29 participants
Primary outcome timeframe
Cycle 1 (28 days)
Results posted on
2026-05-12
Participant Flow
First participant signed informed consent on 24 November 2022. Last participant last visit occurred on 08 April 2025.
Of 38 screened participants, 29 met eligibility criteria and were included in the trial. This was a Phase 1 trial with 2 parts: a dose-escalation using a modified 3+3 design with 6 dose escalation cohorts at increasing dose levels and an expansion part. The trial was terminated prematurely at the end of the dose-escalation based on Sponsor's strategic decision.
Participant milestones
| Measure |
DT-9081 Dose-escalation Cohort 1
Dose-escalation cohort 1 (DT-9081 25 mg/day)
|
DT-9081 Dose-escalation Cohort 2
Dose-escalation cohort 2 (DT-9081 50 mg/day)
|
DT-9081 Dose-escalation Cohort 3
Dose-escalation cohort 3 (DT-9081 100 mg/day)
|
DT-9081 Dose-escalation Cohort 4
Dose-escalation cohort 4 (DT-9081 200 mg/kg)
|
DT-9081 Dose-escalation Cohort 5
Dose-escalation cohort 5 (DT-9081 400 mg/day)
|
DT-9081 Dose-escalation Cohort 6
Dose-escalation cohort 6 (DT-9081 600 mg/day)
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
7
|
4
|
3
|
5
|
7
|
|
Overall Study
COMPLETED
|
0
|
3
|
2
|
1
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
2
|
2
|
3
|
6
|
Reasons for withdrawal
| Measure |
DT-9081 Dose-escalation Cohort 1
Dose-escalation cohort 1 (DT-9081 25 mg/day)
|
DT-9081 Dose-escalation Cohort 2
Dose-escalation cohort 2 (DT-9081 50 mg/day)
|
DT-9081 Dose-escalation Cohort 3
Dose-escalation cohort 3 (DT-9081 100 mg/day)
|
DT-9081 Dose-escalation Cohort 4
Dose-escalation cohort 4 (DT-9081 200 mg/kg)
|
DT-9081 Dose-escalation Cohort 5
Dose-escalation cohort 5 (DT-9081 400 mg/day)
|
DT-9081 Dose-escalation Cohort 6
Dose-escalation cohort 6 (DT-9081 600 mg/day)
|
|---|---|---|---|---|---|---|
|
Overall Study
Death
|
1
|
0
|
1
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
0
|
1
|
1
|
1
|
|
Overall Study
Other reason
|
0
|
2
|
1
|
0
|
1
|
4
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
DT-9081 Dose-escalation Cohort 1
n=3 Participants
Dose-escalation cohort 1 (DT-9081 25 mg/day)
|
DT-9081 Dose-escalation Cohort 2
n=7 Participants
Dose-escalation cohort 2 (DT-9081 50 mg/day)
|
DT-9081 Dose-escalation Cohort 3
n=4 Participants
Dose-escalation cohort 3 (DT-9081 100 mg/day)
|
DT-9081 Dose-escalation Cohort 4
n=3 Participants
Dose-escalation cohort 4 (DT-9081 200 mg/kg)
|
DT-9081 Dose-escalation Cohort 5
n=5 Participants
Dose-escalation cohort 5 (DT-9081 400 mg/day)
|
DT-9081 Dose-escalation Cohort 6
n=7 Participants
Dose-escalation cohort 6 (DT-9081 600 mg/day)
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Sex: Female, Male
Male
|
1 Participants
n=3 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=3 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
14 Participants
n=29 Participants
|
|
Age, Customized
Age
|
65.0 years
n=3 Participants
|
64.0 years
n=7 Participants
|
65.5 years
n=4 Participants
|
57.0 years
n=3 Participants
|
59.0 years
n=5 Participants
|
50 years
n=7 Participants
|
59.0 years
n=29 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=3 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
15 Participants
n=29 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
ECOG (Eastern Cooperative Oncology Group) performance status
0
|
2 Participants
n=3 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
15 Participants
n=29 Participants
|
|
ECOG (Eastern Cooperative Oncology Group) performance status
1
|
1 Participants
n=3 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=29 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (28 days)Population: Number of participants with DLT
Number of participants with dose-limiting toxicities (DLTs).
Outcome measures
| Measure |
DT-9081 Dose-escalation Cohort 1
n=3 Participants
Dose-escalation cohort 1 (DT-9081 25 mg/day)
|
DT-9081 Dose-escalation Cohort 2
n=7 Participants
Dose-escalation cohort 2 (DT-9081 50 mg/day)
|
DT-9081 Dose-escalation Cohort 3
n=4 Participants
Dose-escalation cohort 3 (DT-9081 100 mg/day)
|
DT-9081 Dose-escalation Cohort 4
n=3 Participants
Dose-escalation cohort 4 (DT-9081 200 mg/kg)
|
DT-9081 Dose-escalation Cohort 5
n=5 Participants
Dose-escalation cohort 5 (DT-9081 400 mg/day)
|
DT-9081 Dose-escalation Cohort 6
n=7 Participants
Dose-escalation cohort 6 (DT-9081 600 mg/day)
|
|---|---|---|---|---|---|---|
|
Dose Escalation: Safety Assessment (by Reporting the Number of Participants With DLTs)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
DT-9081 Dose-escalation Cohort 1
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
DT-9081 Dose-escalation Cohort 2
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
DT-9081 Dose-escalation Cohort 3
Serious events: 1 serious events
Other events: 4 other events
Deaths: 1 deaths
DT-9081 Dose-escalation Cohort 4
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
DT-9081 Dose-escalation Cohort 5
Serious events: 1 serious events
Other events: 5 other events
Deaths: 1 deaths
DT-9081 Dose-escalation Cohort 6
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DT-9081 Dose-escalation Cohort 1
n=3 participants at risk
Dose-escalation cohort 1 (DT-9081 25 mg/day)
|
DT-9081 Dose-escalation Cohort 2
n=7 participants at risk
Dose-escalation cohort 2 (DT-9081 50 mg/day)
|
DT-9081 Dose-escalation Cohort 3
n=4 participants at risk
Dose-escalation cohort 3 (DT-9081 100 mg/day)
|
DT-9081 Dose-escalation Cohort 4
n=3 participants at risk
Dose-escalation cohort 4 (DT-9081 200 mg/kg)
|
DT-9081 Dose-escalation Cohort 5
n=5 participants at risk
Dose-escalation cohort 5 (DT-9081 400 mg/day)
|
DT-9081 Dose-escalation Cohort 6
n=7 participants at risk
Dose-escalation cohort 6 (DT-9081 600 mg/day)
|
|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
25.0%
1/4 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/5 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
14.3%
1/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/4 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/5 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
25.0%
1/4 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/5 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/4 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
20.0%
1/5 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/4 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/5 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
14.3%
1/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
Other adverse events
| Measure |
DT-9081 Dose-escalation Cohort 1
n=3 participants at risk
Dose-escalation cohort 1 (DT-9081 25 mg/day)
|
DT-9081 Dose-escalation Cohort 2
n=7 participants at risk
Dose-escalation cohort 2 (DT-9081 50 mg/day)
|
DT-9081 Dose-escalation Cohort 3
n=4 participants at risk
Dose-escalation cohort 3 (DT-9081 100 mg/day)
|
DT-9081 Dose-escalation Cohort 4
n=3 participants at risk
Dose-escalation cohort 4 (DT-9081 200 mg/kg)
|
DT-9081 Dose-escalation Cohort 5
n=5 participants at risk
Dose-escalation cohort 5 (DT-9081 400 mg/day)
|
DT-9081 Dose-escalation Cohort 6
n=7 participants at risk
Dose-escalation cohort 6 (DT-9081 600 mg/day)
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
66.7%
2/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
42.9%
3/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
50.0%
2/4 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
33.3%
1/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
80.0%
4/5 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
57.1%
4/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
28.6%
2/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/4 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
33.3%
1/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
20.0%
1/5 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
14.3%
1/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
25.0%
1/4 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
40.0%
2/5 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
28.6%
2/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
28.6%
2/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/4 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
20.0%
1/5 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
14.3%
1/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/4 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
33.3%
1/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/5 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
28.6%
2/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/4 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
33.3%
1/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/5 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
14.3%
1/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
14.3%
1/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/4 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/5 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/4 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/5 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
14.3%
1/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
14.3%
1/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/4 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/5 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/4 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
20.0%
1/5 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
|
General disorders
Asthenia
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
14.3%
1/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
25.0%
1/4 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/5 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
57.1%
4/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
|
General disorders
Fatigue
|
66.7%
2/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
25.0%
1/4 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/5 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
14.3%
1/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
|
General disorders
Chills
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/4 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
33.3%
1/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/5 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
28.6%
2/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
|
General disorders
Pyrexia
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/4 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
33.3%
1/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/5 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
14.3%
1/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
14.3%
1/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/4 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/5 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
14.3%
1/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/4 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/5 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/4 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
20.0%
1/5 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
14.3%
1/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/4 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/5 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/4 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/5 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
14.3%
1/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
|
Investigations
Lipase increased
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
14.3%
1/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/4 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/5 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/4 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
20.0%
1/5 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
28.6%
2/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/4 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
33.3%
1/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
40.0%
2/5 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
28.6%
2/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
14.3%
1/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/4 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/5 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
14.3%
1/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/4 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/5 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
28.6%
2/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
14.3%
1/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/4 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
20.0%
1/5 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
14.3%
1/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/4 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
33.3%
1/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/5 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/4 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/5 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
14.3%
1/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
33.3%
1/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/4 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/5 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/4 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/5 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
14.3%
1/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
14.3%
1/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/4 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/5 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/4 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/5 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
14.3%
1/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
14.3%
1/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/4 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
33.3%
1/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/5 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
14.3%
1/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/4 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/5 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/4 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
20.0%
1/5 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
14.3%
1/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/4 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/5 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/4 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
33.3%
1/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/5 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
|
Nervous system disorders
Migraine
|
33.3%
1/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/4 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/5 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
|
Nervous system disorders
Paraesthesia
|
33.3%
1/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/4 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/5 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/4 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/5 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
14.3%
1/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
|
Psychiatric disorders
Irritability
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/4 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
20.0%
1/5 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/4 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/5 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
14.3%
1/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/4 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/5 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
14.3%
1/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/4 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
20.0%
1/5 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/4 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
20.0%
1/5 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/4 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/3 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
0.00%
0/5 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
14.3%
1/7 • From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60