Trial Outcomes & Findings for E7080 (Lenvatinib) in Combination With Dacarbazine Versus Dacarbazine Alone as First Line Therapy in Patients With Stage IV Melanoma (NCT NCT01133977)
NCT ID: NCT01133977
Last Updated: 2016-10-10
Results Overview
DLTs were defined as clinically significant adverse events (AEs) occurring less than or equal to 21 days after commencing study treatment and considered by the Investigator to be possibly or probably related to study treatment.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
97 participants
Primary outcome timeframe
From Day 1 through 21 days (one cycle)
Results posted on
2016-10-10
Participant Flow
A total of 16 participants were enrolled in the Phase 1b portion of the study; all 16 participants received study treatment. A total of 82 participants were randomized in the Phase 2 portion of the study and a total of 81 participants received treatment. In the Darcarbazine arm, one participant withdrew consent prior to receiving study treatment.
Participant milestones
| Measure |
16 mg Lenvatinib + Dacarbazine (Phase 1b)
Participants received 16 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
|
20 mg Lenvatinib + Dacarbazine (Phase 1b)
Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
|
22 mg Lenvatinib + Dacarbazine (Phase 1b)
Participants received 22 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
|
20 mg Lenvatinib + Dacarbazine (Phase 2)
Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
|
Dacarbazine (Phase 2)
Participants received dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
7
|
6
|
42
|
39
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
3
|
1
|
|
Overall Study
NOT COMPLETED
|
3
|
7
|
6
|
39
|
38
|
Reasons for withdrawal
| Measure |
16 mg Lenvatinib + Dacarbazine (Phase 1b)
Participants received 16 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
|
20 mg Lenvatinib + Dacarbazine (Phase 1b)
Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
|
22 mg Lenvatinib + Dacarbazine (Phase 1b)
Participants received 22 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
|
20 mg Lenvatinib + Dacarbazine (Phase 2)
Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
|
Dacarbazine (Phase 2)
Participants received dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Death
|
1
|
1
|
1
|
7
|
3
|
|
Overall Study
Started a New Line of Therapy
|
2
|
6
|
4
|
25
|
33
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
5
|
1
|
Baseline Characteristics
E7080 (Lenvatinib) in Combination With Dacarbazine Versus Dacarbazine Alone as First Line Therapy in Patients With Stage IV Melanoma
Baseline characteristics by cohort
| Measure |
16 mg Lenvatinib + Dacarbazine (Phase 1b)
n=3 Participants
Participants received 16 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
|
20 mg Lenvatinib + Dacarbazine (Phase 1b)
n=7 Participants
Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
|
22 mg Lenvatinib + Dacarbazine (Phase 1b)
n=6 Participants
Participants received 22 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
|
20 mg Lenvatinib + Dacarbazine (Phase 2)
n=42 Participants
Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
|
Dacarbazine (Phase 2)
n=39 Participants
Participants received dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
18 years and older
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
97 Participants
n=10 Participants
|
|
Sex/Gender, Customized
Male
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
25 participants
n=4 Participants
|
23 participants
n=21 Participants
|
57 participants
n=10 Participants
|
|
Sex/Gender, Customized
Female
|
0 participants
n=5 Participants
|
5 participants
n=7 Participants
|
2 participants
n=5 Participants
|
17 participants
n=4 Participants
|
16 participants
n=21 Participants
|
40 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: From Day 1 through 21 days (one cycle)Population: Safety Analysis Set: All participants enrolled in the Phase 1b portion of this study, except for those who (i) dropped out of the study prior to receiving any study drug, or (ii) were without any safety assessment following the first dose of study drug.
DLTs were defined as clinically significant adverse events (AEs) occurring less than or equal to 21 days after commencing study treatment and considered by the Investigator to be possibly or probably related to study treatment.
Outcome measures
| Measure |
16 mg Lenvatinib + Dacarbazine (Phase 1b)
n=3 Participants
Participants received 16 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit.
|
20 mg Lenvatinib + Dacarbazine (Phase 1b)
n=7 Participants
Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
|
22 mg Lenvatinib + Dacarbazine (Phase 1b)
n=6 Participants
Participants received 22 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
|
20 mg Lenvatinib + Dacarbazine (Phase 2)
Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
|
Dacarbazine (Phase 2)
Participants received dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
|
|---|---|---|---|---|---|
|
Dose Limiting Toxicity (DLT) of Lenvatinib Administered in Combination With Dacarbazine (for Phase 1b)
Participants with DLTs
|
0 Participants with DLT
|
1 Participants with DLT
|
2 Participants with DLT
|
—
|
—
|
|
Dose Limiting Toxicity (DLT) of Lenvatinib Administered in Combination With Dacarbazine (for Phase 1b)
Grade 3 hypertension
|
0 Participants with DLT
|
1 Participants with DLT
|
1 Participants with DLT
|
—
|
—
|
|
Dose Limiting Toxicity (DLT) of Lenvatinib Administered in Combination With Dacarbazine (for Phase 1b)
Grade 3 febrile neutropenia
|
0 Participants with DLT
|
0 Participants with DLT
|
1 Participants with DLT
|
—
|
—
|
|
Dose Limiting Toxicity (DLT) of Lenvatinib Administered in Combination With Dacarbazine (for Phase 1b)
Grade 3 thrombocytopenia
|
0 Participants with DLT
|
0 Participants with DLT
|
1 Participants with DLT
|
—
|
—
|
PRIMARY outcome
Timeframe: From signing of informed consent up to 30 days after the last dose, up to approximately 2 yearsPopulation: Safety Analysis Set: All participants enrolled in the Phase 1b and Phase 2 portion of this study, except for those who (i) dropped out of the study prior to receiving any study drug, or (ii) were without any safety assessment following the first dose of study drug.
Safety assessments consisted of monitoring and recording all AEs, including all Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v. 4.0) grades, and SAEs; regular monitoring of hematology, blood chemistry, and urine values; periodic measurement of vital signs and electrocardiograms (ECGs); and performance of physical examinations. Details of AEs and SAEs are provided in the reported adverse event section.
Outcome measures
| Measure |
16 mg Lenvatinib + Dacarbazine (Phase 1b)
n=3 Participants
Participants received 16 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit.
|
20 mg Lenvatinib + Dacarbazine (Phase 1b)
n=7 Participants
Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
|
22 mg Lenvatinib + Dacarbazine (Phase 1b)
n=6 Participants
Participants received 22 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
|
20 mg Lenvatinib + Dacarbazine (Phase 2)
n=42 Participants
Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
|
Dacarbazine (Phase 2)
n=39 Participants
Participants received dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
|
|---|---|---|---|---|---|
|
Number of Participants With Adverse Events/Serious Adverse Events (AEs/SAEs)
AEs
|
3 Participants
|
7 Participants
|
6 Participants
|
40 Participants
|
31 Participants
|
|
Number of Participants With Adverse Events/Serious Adverse Events (AEs/SAEs)
SAEs
|
2 Participants
|
4 Participants
|
2 Participants
|
16 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From the date of randomization until the date of disease progression or death (whichever was earlier) or up to approximately 2 yearsPopulation: All randomized participants who received at least one dose of study drug without major protocol eligibility violations were included in the Modified Intent-to-Treat (MITT) Analysis Set.
PFS was defined as the time from the date of randomization of a participant until (1) the date of first documented progression of such participant's disease based on Investigator assessments according to Response Evaluation Criteria In Solid Tumors (RECIST v. 1.1) or (2) the date of such participant's death due to any cause. Progression was defined as at least a 20% increase or 5 mm increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions, based on Investigator assessment according to RECIST 1.1. If missing assessments, imputed dates were used in the analysis.
Outcome measures
| Measure |
16 mg Lenvatinib + Dacarbazine (Phase 1b)
n=40 Participants
Participants received 16 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit.
|
20 mg Lenvatinib + Dacarbazine (Phase 1b)
n=37 Participants
Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
|
22 mg Lenvatinib + Dacarbazine (Phase 1b)
Participants received 22 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
|
20 mg Lenvatinib + Dacarbazine (Phase 2)
Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
|
Dacarbazine (Phase 2)
Participants received dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
|
|---|---|---|---|---|---|
|
Progression Free Survival (PFS) (for Phase 2)
|
19.1 Weeks
Interval 9.57 to 25.57
|
7.0 Weeks
Interval 5.57 to 15.57
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From the date of randomization until disease progression or death or up to approximately 2 yearsTTP, defined as the time from the date of randomization until the date of progressive disease.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From the date of randomization until death or up to approximately 2 yearsOS, defined as the time from the date of randomization until the date of death. Few events of deaths (9 events in the Lenvatinib + Dacarbazine arm and 4 events in the Dacarbazine arm) were reported to calculate the median OS or to draw conclusions regarding the OS.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From the date of randomization until disease progression or death or up to approximately 2 yearsORR, defined as percentage of participants with best confirmed response (complete response \[CR\] or partial response \[PR\]). A confirmatory scan was required after no less than 4 weeks and no later than 8 weeks, starting on the date that the response was first recorded.
Outcome measures
Outcome data not reported
Adverse Events
16 mg Lenvatinib + Dacarbazine (Phase 1b)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
20 mg Lenvatinib + Dacarbazine (Phase 1b)
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
22 mg Lenvatinib + Dacarbazine (Phase 1b)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
20 mg Lenvatinib + Dacarbazine (Phase 2)
Serious events: 16 serious events
Other events: 40 other events
Deaths: 0 deaths
Dacarbazine (Phase 2)
Serious events: 1 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
16 mg Lenvatinib + Dacarbazine (Phase 1b)
n=3 participants at risk
Participants received 16 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
|
20 mg Lenvatinib + Dacarbazine (Phase 1b)
n=7 participants at risk
Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
|
22 mg Lenvatinib + Dacarbazine (Phase 1b)
n=6 participants at risk
Participants received 22 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
|
20 mg Lenvatinib + Dacarbazine (Phase 2)
n=42 participants at risk
Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
|
Dacarbazine (Phase 2)
n=39 participants at risk
Participants received dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
16.7%
1/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
16.7%
1/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.4%
1/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.4%
1/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.4%
1/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.4%
1/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
33.3%
1/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.4%
1/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
16.7%
1/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.4%
1/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.4%
1/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Gastrointestinal disorders
Intestinal Perforation
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.4%
1/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Gastrointestinal disorders
Ileus
|
33.3%
1/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
General disorders
Asthenia
|
33.3%
1/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
General disorders
Chest pain
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
General disorders
Fatigue
|
33.3%
1/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.6%
1/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Investigations
White Blood Cell Count Increased
|
33.3%
1/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Infections and infestations
Abscess
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.4%
1/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.4%
1/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Infections and infestations
Intertrigo Candida
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.4%
1/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.4%
1/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Infections and infestations
Postoperative Wound Infection
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.4%
1/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
1/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.4%
1/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.4%
1/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Nervous system disorders
Partial Seizures
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.4%
1/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.4%
1/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Reproductive system and breast disorders
Breast Swelling
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.4%
1/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
16.7%
1/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.4%
1/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.4%
1/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Social circumstances
Physical Disability
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.4%
1/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Vascular disorders
Hypertention
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.4%
1/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
Other adverse events
| Measure |
16 mg Lenvatinib + Dacarbazine (Phase 1b)
n=3 participants at risk
Participants received 16 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
|
20 mg Lenvatinib + Dacarbazine (Phase 1b)
n=7 participants at risk
Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
|
22 mg Lenvatinib + Dacarbazine (Phase 1b)
n=6 participants at risk
Participants received 22 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
|
20 mg Lenvatinib + Dacarbazine (Phase 2)
n=42 participants at risk
Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
|
Dacarbazine (Phase 2)
n=39 participants at risk
Participants received dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
|
|---|---|---|---|---|---|
|
Nervous system disorders
DYSAESTHESIA
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
16.7%
1/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Nervous system disorders
DYSGEUSIA
|
33.3%
1/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.4%
1/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
7.7%
3/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Nervous system disorders
HEADACHE
|
33.3%
1/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
57.1%
4/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
16.7%
1/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
9.5%
4/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
7.7%
3/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Nervous system disorders
LETHARGY
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
16.7%
1/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.4%
1/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Nervous system disorders
MIGRAINE
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
7.1%
3/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.6%
1/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Nervous system disorders
PARAESTHESIA
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
4.8%
2/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
5.1%
2/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
7.1%
3/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Psychiatric disorders
DEPRESSION
|
33.3%
1/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
4.8%
2/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Psychiatric disorders
DISORIENTATION
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Psychiatric disorders
INSOMNIA
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
16.7%
1/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.4%
1/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.6%
1/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Renal and urinary disorders
DYSURIA
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.4%
1/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Renal and urinary disorders
PROTEINURIA
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
19.0%
8/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
5.1%
2/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Renal and urinary disorders
RENAL IMPAIRMENT
|
33.3%
1/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Reproductive system and breast disorders
BREAST DISORDER
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Reproductive system and breast disorders
MENSTRUATION IRREGULAR
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Reproductive system and breast disorders
VULVOVAGINAL DRYNESS
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
28.6%
2/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
16.7%
1/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
11.9%
5/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
10.3%
4/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
42.9%
3/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
33.3%
2/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
26.2%
11/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
33.3%
1/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
4.8%
2/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.6%
1/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
16.7%
1/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.4%
1/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Respiratory, thoracic and mediastinal disorders
HICCUPS
|
66.7%
2/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
4.8%
2/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
50.0%
3/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.4%
1/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.6%
1/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGEAL ERYTHEMA
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.6%
1/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Respiratory, thoracic and mediastinal disorders
RHINITIS ALLERGIC
|
33.3%
1/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.6%
1/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Skin and subcutaneous tissue disorders
ACNE
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.4%
1/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
33.3%
1/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
16.7%
1/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
16.7%
1/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.4%
1/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.6%
1/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
33.3%
1/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
7.1%
3/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
5.1%
2/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Skin and subcutaneous tissue disorders
PAIN OF SKIN
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.4%
1/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.6%
1/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
9.5%
4/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.6%
1/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Skin and subcutaneous tissue disorders
RASH
|
33.3%
1/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
28.6%
2/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
16.7%
1/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
7.1%
3/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Skin and subcutaneous tissue disorders
SKIN EXFOLIATION
|
33.3%
1/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Vascular disorders
FLUSHING
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.4%
1/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
5.1%
2/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Vascular disorders
HYPERTENSION
|
33.3%
1/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
85.7%
6/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
83.3%
5/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
47.6%
20/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
5.1%
2/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Vascular disorders
HYPERTENSIVE CRISIS
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
16.7%
1/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
16.7%
1/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
9.5%
4/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Vascular disorders
PHLEBITIS
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Vascular disorders
VASCULITIS
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
33.3%
1/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
9.5%
4/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
10.3%
4/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
4.8%
2/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
5.1%
2/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
66.7%
2/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
42.9%
3/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
33.3%
2/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
23.8%
10/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
10.3%
4/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
66.7%
2/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
42.9%
3/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
33.3%
2/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
11.9%
5/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.6%
1/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Cardiac disorders
CONDUCTION DISORDER
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
16.7%
1/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Ear and labyrinth disorders
VERTIGO
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
4.8%
2/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
5.1%
2/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
33.3%
1/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
28.6%
2/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
16.7%
7/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
11.9%
5/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
66.7%
2/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
42.9%
3/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
16.7%
1/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
6/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.6%
1/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Gastrointestinal disorders
CONSTIPATION
|
33.3%
1/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
57.1%
4/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
16.7%
1/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
33.3%
14/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
35.9%
14/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Gastrointestinal disorders
DIARRHOEA
|
33.3%
1/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
57.1%
4/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
33.3%
2/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
31.0%
13/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
15.4%
6/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Gastrointestinal disorders
DIVERTICULUM
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Gastrointestinal disorders
DRY MOUTH
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
11.9%
5/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.6%
1/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
33.3%
1/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
28.6%
2/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
19.0%
8/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
33.3%
1/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.4%
1/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Gastrointestinal disorders
FLATULENCE
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
9.5%
4/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.4%
1/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Gastrointestinal disorders
NAUSEA
|
66.7%
2/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
71.4%
5/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
66.7%
4/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
38.1%
16/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
28.2%
11/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Gastrointestinal disorders
ORAL PAIN
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.4%
1/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Gastrointestinal disorders
STOMATITIS
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
42.9%
3/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
16.7%
1/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
4.8%
2/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.6%
1/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Gastrointestinal disorders
TOOTHACHE
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
7.1%
3/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Gastrointestinal disorders
VOMITING
|
66.7%
2/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
57.1%
4/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
23.8%
10/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
10.3%
4/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
General disorders
ASTHENIA
|
33.3%
1/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
42.9%
3/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
16.7%
1/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
16.7%
7/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
17.9%
7/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
General disorders
CATHETER SITE PAIN
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.4%
1/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
General disorders
CHILLS
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
7.7%
3/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
General disorders
FATIGUE
|
66.7%
2/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
71.4%
5/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
33.3%
2/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
23.8%
10/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
17.9%
7/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
General disorders
INFUSION SITE REACTION
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
16.7%
1/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
General disorders
MUCOSAL INFLAMMATION
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
7.1%
3/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
General disorders
PAIN
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
28.6%
2/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
16.7%
1/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
9.5%
4/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
General disorders
PYREXIA
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
28.6%
2/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
16.7%
7/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.6%
1/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Infections and infestations
CONJUNCTIVITIS VIRAL
|
33.3%
1/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Infections and infestations
CYSTITIS
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.6%
1/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Infections and infestations
DEVICE RELATED INFECTION
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Infections and infestations
FOLLICULITIS
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.4%
1/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Infections and infestations
HORDEOLUM
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
5.1%
2/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
7.1%
3/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
10.3%
4/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Infections and infestations
ORAL FUNGAL INFECTION
|
33.3%
1/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Infections and infestations
RHINITIS
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
5.1%
2/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
4.8%
2/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
16.7%
1/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.4%
1/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
66.7%
2/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
9.5%
4/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
7.7%
3/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Injury, poisoning and procedural complications
BAROTRAUMA
|
33.3%
1/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
42.9%
3/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
11.9%
5/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
7.7%
3/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
28.6%
2/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
7.1%
3/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
5.1%
2/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
5.1%
2/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
16.7%
1/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.4%
1/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Investigations
BLOOD URIC ACID INCREASED
|
33.3%
1/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
7.1%
3/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
5.1%
2/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
28.6%
2/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.4%
1/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Investigations
PLATELET COUNT DECREASED
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
28.6%
2/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
7.1%
3/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.6%
1/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Investigations
WEIGHT DECREASED
|
66.7%
2/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
7.1%
3/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
33.3%
1/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
71.4%
5/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
23.8%
10/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.6%
1/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
66.7%
2/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.6%
1/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
9.5%
4/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.6%
1/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
16.7%
1/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
4.8%
2/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.6%
1/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
33.3%
1/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
28.6%
2/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
16.7%
1/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
16.7%
7/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
7.7%
3/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Musculoskeletal and connective tissue disorders
JOINT SWELLING
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.4%
1/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
5.1%
2/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
16.7%
1/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.4%
1/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
7.1%
3/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.6%
1/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
4.8%
2/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
5.1%
2/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
33.3%
1/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
11.9%
5/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
5.1%
2/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT MELANOMA
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SKIN PAPILLOMA
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF SKIN
|
33.3%
1/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SUPERFICIAL SPREADING MELANOMA STAGE UNSPECIFIED
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Nervous system disorders
CARPAL TUNNEL SYNDROME
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/3 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
14.3%
1/7 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
0.00%
0/6 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
4.8%
2/42 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
2.6%
1/39 • From signing of informed consent up to 30 days after the last dose, up to approximately 2 years.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug are reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER