Trial Outcomes & Findings for Safety and Efficacy of Cabazitaxel in Pediatric Patients With Refractory Solid Tumors Including Central Nervous System Tumors (NCT NCT01751308)
NCT ID: NCT01751308
Last Updated: 2016-08-12
Results Overview
MTD was highest dose level of cabazitaxel at which no more than 1 of 6 evaluable participants experienced dose limiting toxicities (DLT). DLT defined as an AE or abnormal laboratory values related to study treatment: hematologic DLTs: any Grade(G)4 hematologic toxicity except neutropenia G4 lasting≤7 days,G3 or 4 febrile neutropenia except G3 or 4 febrile neutropenia in absence of granulocyte-colony stimulating factor prophylaxis, G4 thrombocytopenia; non-hematologic DLTs:any G≥3 non-hematologic toxicity except G3 nausea or G3 or4 vomiting, G3 or4 diarrhea,G3 or4 dehydration,G3 fatigue lasting≤7 days, inadequately treated hypersensitivity reactions, elevated transaminases\<10\* upper limit of normal of ≤7 days, re-treatment delay of\>2 weeks due to delayed recovery from toxicity related to study treatment to baseline G or≤ G1(except for alopecia) and platelet transfusion during Cycle1. Grades based on National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
39 participants
Primary outcome timeframe
Cycle 1 (21 days)
Results posted on
2016-08-12
Participant Flow
Participants were enrolled at 12 centers between February 2013 and March 2015.
Phase I was a dose escalation part of Cabazitaxel to determine maximum tolerated dose (MTD). Phase 2 was efficacy and safety evaluation of Cabazitaxel at the MTD, determined in Phase 1.
Participant milestones
| Measure |
Phase 1: Cabazitaxel 20 mg/m^2
Cabazitaxel 20 mg/m\^2 intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression (DP) or discontinuation due to adverse events (AE) or death (from any cause).
|
Phase 1: Cabazitaxel 25 mg/m^2
Cabazitaxel 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 1: Cabazitaxel 30 mg/m^2
Cabazitaxel 30 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 1: Cabazitaxel 35 mg/m^2
Cabazitaxel 35 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 2: Cabazitaxel 30 mg/m^2
Cabazitaxel at the MTD as determined in phase 1 (30 mg/m\^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
|---|---|---|---|---|---|
|
Phase 1
STARTED
|
6
|
3
|
7
|
7
|
0
|
|
Phase 1
COMPLETED
|
6
|
3
|
7
|
7
|
0
|
|
Phase 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Phase 2
STARTED
|
0
|
0
|
0
|
0
|
16
|
|
Phase 2
COMPLETED
|
0
|
0
|
0
|
0
|
16
|
|
Phase 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of Cabazitaxel in Pediatric Patients With Refractory Solid Tumors Including Central Nervous System Tumors
Baseline characteristics by cohort
| Measure |
Phase 1: Cabazitaxel 20 mg/m^2
n=6 Participants
Cabazitaxel 20 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 1: Cabazitaxel 25 mg/m^2
n=3 Participants
Cabazitaxel 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 1: Cabazitaxel 30 mg/m^2
n=7 Participants
Cabazitaxel 30 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 1: Cabazitaxel 35 mg/m^2
n=7 Participants
Cabazitaxel 35 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 2: Cabazitaxel 30 mg/m^2
n=16 Participants
Cabazitaxel at the maximum tolerated dose (MTD) as determined in phase 1 (30 mg/m\^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
2-4 years
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
2 participants
n=27 Participants
|
0 participants
n=483 Participants
|
2 participants
n=36 Participants
|
4 participants
n=10 Participants
|
|
Age, Customized
5-6 years
|
2 participants
n=93 Participants
|
1 participants
n=4 Participants
|
0 participants
n=27 Participants
|
1 participants
n=483 Participants
|
4 participants
n=36 Participants
|
8 participants
n=10 Participants
|
|
Age, Customized
7-11 years
|
1 participants
n=93 Participants
|
1 participants
n=4 Participants
|
3 participants
n=27 Participants
|
5 participants
n=483 Participants
|
4 participants
n=36 Participants
|
14 participants
n=10 Participants
|
|
Age, Customized
12-18 years
|
3 participants
n=93 Participants
|
1 participants
n=4 Participants
|
2 participants
n=27 Participants
|
1 participants
n=483 Participants
|
6 participants
n=36 Participants
|
13 participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
16 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
23 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (21 days)Population: DLT evaluable population defined as a subset of participants in the Phase 1 part of the study from the AT population who received the first dose of cabazitaxel and had sufficient safety evaluations or experienced a DLT during Cycle 1.
MTD was highest dose level of cabazitaxel at which no more than 1 of 6 evaluable participants experienced dose limiting toxicities (DLT). DLT defined as an AE or abnormal laboratory values related to study treatment: hematologic DLTs: any Grade(G)4 hematologic toxicity except neutropenia G4 lasting≤7 days,G3 or 4 febrile neutropenia except G3 or 4 febrile neutropenia in absence of granulocyte-colony stimulating factor prophylaxis, G4 thrombocytopenia; non-hematologic DLTs:any G≥3 non-hematologic toxicity except G3 nausea or G3 or4 vomiting, G3 or4 diarrhea,G3 or4 dehydration,G3 fatigue lasting≤7 days, inadequately treated hypersensitivity reactions, elevated transaminases\<10\* upper limit of normal of ≤7 days, re-treatment delay of\>2 weeks due to delayed recovery from toxicity related to study treatment to baseline G or≤ G1(except for alopecia) and platelet transfusion during Cycle1. Grades based on National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
Outcome measures
| Measure |
Phase 1: Overall Population
n=23 Participants
Cabazitaxel 20 mg/m\^2, 25 mg/m\^2, 30 mg/m\^2 or 35 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 1: Cabazitaxel 25 mg/m^2
Cabazitaxel 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 1: Cabazitaxel 30 mg/m^2
Cabazitaxel 30 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 1: Cabazitaxel 35 mg/m^2
Cabazitaxel 35 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 2: Cabazitaxel 30 mg/m^2
Cabazitaxel at the maximum tolerated dose (MTD) as determined in phase 1 (30 mg/m\^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
|---|---|---|---|---|---|
|
Phase 1: Maximum Tolerated Dose of Cabazitaxel
|
30 mg/m^2
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, every 9 weeks until DP or death due to any cause (maximum duration: 12.1 weeks)Population: Efficacy evaluable population was subset of AT population with measurable disease with a baseline and at least one post-baseline tumor evaluation.Number of participants analyzed=participants with available data for this endpoint.
OR in participants was defined as the participants with a Complete Response (CR) or Partial Response (PR) after 3 cycles of cabazitaxel treatment and maintained for at least 4 weeks. CR and PR were based on modified response assessment in neuro-oncology (RANO) criteria for participants with CNS tumors. CR was defined as disappearance of all target lesions. PR was defined as ≥50% decrease in the sum of the products of the two perpendicular diameters of target lesions, compared to the baseline measurement.
Outcome measures
| Measure |
Phase 1: Overall Population
n=11 Participants
Cabazitaxel 20 mg/m\^2, 25 mg/m\^2, 30 mg/m\^2 or 35 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 1: Cabazitaxel 25 mg/m^2
Cabazitaxel 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 1: Cabazitaxel 30 mg/m^2
Cabazitaxel 30 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 1: Cabazitaxel 35 mg/m^2
Cabazitaxel 35 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 2: Cabazitaxel 30 mg/m^2
Cabazitaxel at the maximum tolerated dose (MTD) as determined in phase 1 (30 mg/m\^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
|---|---|---|---|---|---|
|
Phase 2: Percentage of Participants With Objective Response (OR)
CR
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Phase 2: Percentage of Participants With Objective Response (OR)
PR
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, every 9 weeks until DP or death due to any cause (maximum duration: 12.1 weeks)Population: Due to no objective responses in Stage 1 of Phase 2, the analysis of duration of response was not performed.Hence, the data is not reported.
DOR defined as time (in days) from date of first response until date of first documented progressive disease (PD) or death (from any cause), whichever came first. If progression or death was not observed, participant was censored at the date of participant's last progression-free tumor assessment prior to study cut-off date. PD as per RANO criteria was defined as ≥ 25% increase in the product of perpendicular diameters of any target lesion, taking as reference the smallest product observed since the start of treatment or the appearance of one or more new lesions, or worsening neurologic status not explained by causes unrelated to tumor progression (example, anticonvulsant or corticosteroid toxicity, electrolyte disturbances, sepsis, hyperglycemia, presumed post-therapy swelling etc.) plus any increase in tumor cross-sectional area (or tumor volume).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to DP or death due to any cause (maximum duration: 112.1 weeks for Phase 1 and 12.1 weeks for Phase 2)Population: Analysis was performed on safety population (AT population).
AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had a causal relationship with the treatment. Treatment emergent adverse events (TEAEs) were defined as AEs that developed or worsened in grade or became serious during the on-treatment period which was defined as the period from the time of first dose of cabazitaxel until 30 days following the last administration of cabazitaxel.
Outcome measures
| Measure |
Phase 1: Overall Population
n=6 Participants
Cabazitaxel 20 mg/m\^2, 25 mg/m\^2, 30 mg/m\^2 or 35 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 1: Cabazitaxel 25 mg/m^2
n=3 Participants
Cabazitaxel 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 1: Cabazitaxel 30 mg/m^2
n=7 Participants
Cabazitaxel 30 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 1: Cabazitaxel 35 mg/m^2
n=7 Participants
Cabazitaxel 35 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 2: Cabazitaxel 30 mg/m^2
n=16 Participants
Cabazitaxel at the maximum tolerated dose (MTD) as determined in phase 1 (30 mg/m\^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
|---|---|---|---|---|---|
|
Phase 1 and 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
6 participants
|
3 participants
|
7 participants
|
7 participants
|
16 participants
|
SECONDARY outcome
Timeframe: Baseline, every 9 weeks until DP or death due to any cause (maximum duration: 112.1 weeks)Population: Analysis was performed on efficacy evaluable population. Number of participants analyzed=participants with available data for this endpoint.
OR in participants was defined as the participants with a CR or PR after 3 cycles of cabazitaxel treatment and maintained for at least 4 weeks as assessed by response evaluation criteria in solid tumors (RECIST) version 1.1 and RANO criteria for CNS tumors. For solid tumors, as per RECIST 1.1, CR defined as disappearance of all target and non-target lesions (any pathological lymph nodes, must had reduction in short axis to \<10 mm); PR defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. For CNS tumors, as per RANO criteria, CR defined as disappearance of all target and non-target lesions; PR defined as a ≥50% decrease in the sum of the products of the two perpendicular diameters of target lesions, compared to baseline measurement.
Outcome measures
| Measure |
Phase 1: Overall Population
n=5 Participants
Cabazitaxel 20 mg/m\^2, 25 mg/m\^2, 30 mg/m\^2 or 35 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 1: Cabazitaxel 25 mg/m^2
n=3 Participants
Cabazitaxel 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 1: Cabazitaxel 30 mg/m^2
n=7 Participants
Cabazitaxel 30 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 1: Cabazitaxel 35 mg/m^2
n=7 Participants
Cabazitaxel 35 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 2: Cabazitaxel 30 mg/m^2
Cabazitaxel at the maximum tolerated dose (MTD) as determined in phase 1 (30 mg/m\^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
|---|---|---|---|---|---|
|
Phase 1: Number of Participants With Objective Response
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 of Cycle 1: 5 minutes before EOI up to 71 hours after the EOIPopulation: PK population (for both Phase 1 and Phase 2 parts of the study) included all participants who received treatment on Day 1 of Cycle 1 and had at least one post-dose PK sample. Number of participants analyzed=participants with available data for this endpoint.
Blood samples for PK parameters were collected at 5 minutes before end of infusion (EOI), 10 minutes, 30 minutes, 3 hours, 7 hours and 71 hours after the EOI on Day 1 of Cycle 1.
Outcome measures
| Measure |
Phase 1: Overall Population
n=6 Participants
Cabazitaxel 20 mg/m\^2, 25 mg/m\^2, 30 mg/m\^2 or 35 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 1: Cabazitaxel 25 mg/m^2
n=3 Participants
Cabazitaxel 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 1: Cabazitaxel 30 mg/m^2
n=20 Participants
Cabazitaxel 30 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 1: Cabazitaxel 35 mg/m^2
n=2 Participants
Cabazitaxel 35 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 2: Cabazitaxel 30 mg/m^2
Cabazitaxel at the maximum tolerated dose (MTD) as determined in phase 1 (30 mg/m\^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
|---|---|---|---|---|---|
|
Phase 1 and 2: Pharmacokinetics (PK) Parameter of Cabazitaxel: Area Under the Plasma Concentration (AUC) Versus Time Curve
|
669.5 ng.h/mL
Standard Deviation 430.6
|
879.0 ng.h/mL
Standard Deviation 414.7
|
876.7 ng.h/mL
Standard Deviation 359.9
|
1002.5 ng.h/mL
Standard Deviation 277.9
|
—
|
SECONDARY outcome
Timeframe: Day 1 of Cycle 1: 5 minutes before EOI up to 71 hours after the EOIPopulation: Analysis was performed on PK population (for both Phase 1 and Phase 2 parts of the study). Number of participants analyzed=participants with available data for this endpoint.
Blood samples for PK parameters were collected at 5 minutes before EOI, 10 minutes, 30 minutes, 3 hours, 7 hours and 71 hours after the EOI on Day 1 of Cycle 1.
Outcome measures
| Measure |
Phase 1: Overall Population
n=6 Participants
Cabazitaxel 20 mg/m\^2, 25 mg/m\^2, 30 mg/m\^2 or 35 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 1: Cabazitaxel 25 mg/m^2
n=3 Participants
Cabazitaxel 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 1: Cabazitaxel 30 mg/m^2
n=20 Participants
Cabazitaxel 30 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 1: Cabazitaxel 35 mg/m^2
n=2 Participants
Cabazitaxel 35 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 2: Cabazitaxel 30 mg/m^2
Cabazitaxel at the maximum tolerated dose (MTD) as determined in phase 1 (30 mg/m\^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
|---|---|---|---|---|---|
|
Phase 1 and 2: PK Parameter of Cabazitaxel: Total Plasma Clearance (CL)
|
36.05 L/h/m^2
Standard Deviation 12.91
|
32.76 L/h/m^2
Standard Deviation 12.72
|
38.70 L/h/m^2
Standard Deviation 12.98
|
36.61 L/h/m^2
Standard Deviation 9.98
|
—
|
SECONDARY outcome
Timeframe: Day 1 of Cycle 1: 5 minutes before EOI up to 71 hours after the EOIPopulation: Analysis was performed on PK population (for both Phase 1 and Phase 2 parts of the study). Number of participants analyzed=participants with available data for this endpoint.
Blood samples for PK parameters were collected at 5 minutes before EOI, 10 minutes, 30 minutes, 3 hours, 7 hours and 71 hours after the EOI on Day 1 of Cycle 1.
Outcome measures
| Measure |
Phase 1: Overall Population
n=6 Participants
Cabazitaxel 20 mg/m\^2, 25 mg/m\^2, 30 mg/m\^2 or 35 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 1: Cabazitaxel 25 mg/m^2
n=3 Participants
Cabazitaxel 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 1: Cabazitaxel 30 mg/m^2
n=20 Participants
Cabazitaxel 30 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 1: Cabazitaxel 35 mg/m^2
n=2 Participants
Cabazitaxel 35 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 2: Cabazitaxel 30 mg/m^2
Cabazitaxel at the maximum tolerated dose (MTD) as determined in phase 1 (30 mg/m\^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
|---|---|---|---|---|---|
|
Phase 1 and 2: PK Parameter of Cabazitaxel: Volume of Distribution at Steady State (Vss)
|
3391.72 L/m^2
Standard Deviation 686.79
|
3301.96 L/m^2
Standard Deviation 351.55
|
3371.30 L/m^2
Standard Deviation 975.98
|
1488.75 L/m^2
Standard Deviation 1179.11
|
—
|
SECONDARY outcome
Timeframe: Day 1 of Cycle 1: 5 minutes before EOI up to 71 hours after the EOIPopulation: Analysis was performed on PK population (for both Phase 1 and Phase 2 parts of the study). Number of participants analyzed=participants with available data for this endpoint.
Blood samples for PK parameters were collected at 5 minutes before EOI, 10 minutes, 30 minutes, 3 hours, 7 hours and 71 hours after the EOI on Day 1 of Cycle 1.
Outcome measures
| Measure |
Phase 1: Overall Population
n=6 Participants
Cabazitaxel 20 mg/m\^2, 25 mg/m\^2, 30 mg/m\^2 or 35 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 1: Cabazitaxel 25 mg/m^2
n=3 Participants
Cabazitaxel 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 1: Cabazitaxel 30 mg/m^2
n=20 Participants
Cabazitaxel 30 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 1: Cabazitaxel 35 mg/m^2
n=2 Participants
Cabazitaxel 35 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 2: Cabazitaxel 30 mg/m^2
Cabazitaxel at the maximum tolerated dose (MTD) as determined in phase 1 (30 mg/m\^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
|---|---|---|---|---|---|
|
Phase 1 and 2: PK Parameter of Cabazitaxel: Maximum Plasma Concentration Observed (Cmax)
|
204.864 ng/mL
Standard Deviation 189.864
|
283.657 ng/mL
Standard Deviation 242.970
|
256.734 ng/mL
Standard Deviation 127.931
|
233.290 ng/mL
Standard Deviation 0.127
|
—
|
SECONDARY outcome
Timeframe: Baseline, every 9 weeks until DP or death due to any cause (maximum duration: 12.1 weeks)Population: Analysis was performed on efficacy evaluable population. Number of participants analyzed=participants with available data for this endpoint.
The PFS was defined as the time (in months) from the date of first dose administration until the date of first documented PD or death (from any cause), whichever came first. If progression or death was not observed, the participant was censored at the date of the participant's last progression-free tumor assessment prior to the study cut-off date. PD as per RANO criteria was defined as ≥25% increase in the product of perpendicular diameters of any target lesion, taking as reference the smallest product observed since the start of treatment or the appearance of one or more new lesions, or worsening neurologic status not explained by causes unrelated to tumor progression (example, anticonvulsant or corticosteroid toxicity, electrolyte disturbances, sepsis, hyperglycemia, presumed post-therapy swelling etc) plus any increase in tumor cross-sectional area (or tumor volume). The analysis was performed by Kaplan-Meier method.
Outcome measures
| Measure |
Phase 1: Overall Population
n=11 Participants
Cabazitaxel 20 mg/m\^2, 25 mg/m\^2, 30 mg/m\^2 or 35 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 1: Cabazitaxel 25 mg/m^2
Cabazitaxel 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 1: Cabazitaxel 30 mg/m^2
Cabazitaxel 30 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 1: Cabazitaxel 35 mg/m^2
Cabazitaxel 35 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 2: Cabazitaxel 30 mg/m^2
Cabazitaxel at the maximum tolerated dose (MTD) as determined in phase 1 (30 mg/m\^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
|---|---|---|---|---|---|
|
Phase 2: Progression Free Survival (PFS)
|
1.3 months
Interval 0.6 to 2.1
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to death or study cut-off (maximum duration: 12.1 weeks)Population: Analysis was performed on efficacy evaluable population. Number of participants analyzed=participants with available data for this endpoint.
OS was defined as the time (in months) from the date of first dose administration until the date of death (from any cause). If death was not observed, the participant was censored at the earliest of the last date the participant was known to be alive and the study cut-off date. The analysis was performed by Kaplan-Meier method.
Outcome measures
| Measure |
Phase 1: Overall Population
n=11 Participants
Cabazitaxel 20 mg/m\^2, 25 mg/m\^2, 30 mg/m\^2 or 35 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 1: Cabazitaxel 25 mg/m^2
Cabazitaxel 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 1: Cabazitaxel 30 mg/m^2
Cabazitaxel 30 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 1: Cabazitaxel 35 mg/m^2
Cabazitaxel 35 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 2: Cabazitaxel 30 mg/m^2
Cabazitaxel at the maximum tolerated dose (MTD) as determined in phase 1 (30 mg/m\^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
|---|---|---|---|---|---|
|
Phase 2: Overall Survival (OS)
|
2.7 months
Interval 1.7 to 4.5
|
—
|
—
|
—
|
—
|
Adverse Events
Phase 1: Cabazitaxel 20 mg/m^2
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase 1: Cabazitaxel 25 mg/m^2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1: Cabazitaxel 30 mg/m^2
Serious events: 5 serious events
Other events: 7 other events
Deaths: 0 deaths
Phase 1: Cabazitaxel 35 mg/m^2
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Phase 2: Cabazitaxel 30 mg/m^2
Serious events: 12 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1: Cabazitaxel 20 mg/m^2
n=6 participants at risk
Cabazitaxel 20 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 1: Cabazitaxel 25 mg/m^2
n=3 participants at risk
Cabazitaxel 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 1: Cabazitaxel 30 mg/m^2
n=7 participants at risk
Cabazitaxel 30 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 1: Cabazitaxel 35 mg/m^2
n=7 participants at risk
Cabazitaxel 35 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 2: Cabazitaxel 30 mg/m^2
n=16 participants at risk
Cabazitaxel at the MTD as determined in phase 1 (30 mg/m\^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
28.6%
2/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
18.8%
3/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
12.5%
2/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
General disorders
Death
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
General disorders
Disease progression
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
18.8%
3/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
General disorders
Fatigue
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
18.8%
3/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Infections and infestations
Gastroenteritis
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Infections and infestations
Stoma site infection
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Infections and infestations
Varicella zoster virus infection
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Brain herniation
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intracranial tumour haemorrhage
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Nervous system disorders
Nerve root compression
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Renal and urinary disorders
Cystitis noninfective
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoventilation
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
Other adverse events
| Measure |
Phase 1: Cabazitaxel 20 mg/m^2
n=6 participants at risk
Cabazitaxel 20 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 1: Cabazitaxel 25 mg/m^2
n=3 participants at risk
Cabazitaxel 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 1: Cabazitaxel 30 mg/m^2
n=7 participants at risk
Cabazitaxel 30 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 1: Cabazitaxel 35 mg/m^2
n=7 participants at risk
Cabazitaxel 35 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
Phase 2: Cabazitaxel 30 mg/m^2
n=16 participants at risk
Cabazitaxel at the MTD as determined in phase 1 (30 mg/m\^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
|
|---|---|---|---|---|---|
|
Cardiac disorders
Tachycardia
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
28.6%
2/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Cardiac disorders
Sinus tachycardia
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Eye disorders
Cataract
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Eye disorders
Eye pain
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Eye disorders
Eyelid pain
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Eye disorders
Vision blurred
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
42.9%
3/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
12.5%
2/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
28.6%
2/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
28.6%
2/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
18.8%
3/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
2/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
57.1%
4/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
31.2%
5/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
37.5%
6/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
42.9%
3/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
28.6%
2/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
31.2%
5/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
66.7%
2/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
42.9%
3/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
28.6%
2/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
25.0%
4/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
General disorders
Catheter site pain
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
General disorders
Device occlusion
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
General disorders
Fatigue
|
33.3%
2/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
28.6%
2/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
42.9%
3/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
18.8%
3/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
General disorders
Gait disturbance
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
General disorders
Localised oedema
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
General disorders
Malaise
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
General disorders
Oedema
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
General disorders
Oedema peripheral
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
General disorders
Pain
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
28.6%
2/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
12.5%
2/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Infections and infestations
Candida infection
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
12.5%
2/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Infections and infestations
Enterocolitis bacterial
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Infections and infestations
Lip infection
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
12.5%
2/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Infections and infestations
Varicella zoster virus infection
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
28.6%
2/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
12.5%
2/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Rectal injury
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Investigations
Candida test positive
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Investigations
Coronavirus test positive
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
28.6%
2/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Investigations
Weight decreased
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
28.6%
2/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
12.5%
2/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Joint hyperextension
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
28.6%
2/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Nervous system disorders
Accessory nerve disorder
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Nervous system disorders
Ataxia
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
28.6%
2/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
12.5%
2/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Nervous system disorders
Cerebellar ataxia
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
12.5%
2/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Nervous system disorders
Cerebellar syndrome
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
12.5%
2/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Nervous system disorders
Cranial nerve paralysis
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
28.6%
2/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
18.8%
3/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Nervous system disorders
Facial nerve disorder
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Nervous system disorders
Headache
|
66.7%
4/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
28.6%
2/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
25.0%
4/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Nervous system disorders
Hemiparesis
|
33.3%
2/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
18.8%
3/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Nervous system disorders
Hypoglossal nerve disorder
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Nervous system disorders
Hypotonia
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
12.5%
2/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Nervous system disorders
Muscle spasticity
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Nervous system disorders
Paraesthesia
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Nervous system disorders
Seizure
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
12.5%
2/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Nervous system disorders
Tremor
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
12.5%
2/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Nervous system disorders
VIIIth nerve lesion
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Nervous system disorders
VIth nerve disorder
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Nervous system disorders
VIth nerve paralysis
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
12.5%
2/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Psychiatric disorders
Deja vu
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Renal and urinary disorders
Haematuria
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Renal and urinary disorders
Pollakiuria
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
66.7%
2/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
42.9%
3/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
12.5%
2/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Vascular disorders
Flushing
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
6.2%
1/16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER